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    Clinical Trial Results:
    An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)

    Summary
    EudraCT number
    		 2015-000111-41
    Trial protocol
    		 ES   DE   BE   IT  
    Global end of trial date
    19 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M14-748
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02486406
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001440-PIP01-13 EMEA-001439-PIP01-13
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric subjects of ≥ 3 to 17 years of age. The study population for Part 1, the PK study, included GT1-infected subjects who were noncirrhotic and treatment-naïve (TN). Part 2, the safety and efficacy study, included GT-1 or GT4-infected subjects ≥ 12 to 17 yrs old who were TN or interferon ([IFN] or Pegylated-interferon alfa-2a or 2b [pegIFN] with or without RBV) treatment-experienced (TE) without cirrhosis or with compensated cirrhosis. In Part 1 and Part 2, the treatment regimen and duration were dependent on HCV GT, GT1 subtype, and cirrhosis status.
    Protection of trial subjects
    The investigator or his/her representative explained the nature of the study to the subject's parent(s)/legal guardian(s) and answered all questions regarding the study. Pediatric subjects were to be included in all the discussions in order to obtain written assent. Prior to any study-related screening procedures being performed on the subject, the informed consent statement was to be reviewed and signed and dated by subject's parent(s)/legal guardian(s) and the person who administered the informed consent, and any other signatories according to local requirements. Additionally, in keeping with each institution's IEC requirements, if applicable, an informed assent form will also to be obtained by each subject, as appropriate for age and country, prior to any study-related procedures being performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United States: 44
    Worldwide total number of subjects
    64
    EEA total number of subjects
    18
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    26
    Adolescents (12-17 years)
    38
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Safety population: all participants who received at least one dose of study drug in Part 1 or Part 2

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adult tablet, 12-17 yr, Part 1
    Arm description
    		 Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Ombitasvir also known as ABT-267, paritaprevir also known as ABT-450, Ombitsvir/paritaprevir/ritonavir also known as Viekirax
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the adult OBV/PTV/RTV formulation: two 12.5 mg ombitasvir /75 mg paritaprevir/50 mg ritonavir tablets taken orally every morning (QD) for 12 weeks.

    Investigational medicinal product name
    Dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg tablets were administered orally for 12 weeks per local label for those participants with HCV GT1a.

    Arm title
    		 Adult tablet, 12-17 yr, Part 2
    Arm description
    		 Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Ombitasvir also known as ABT-267, paritaprevir also known as ABT-450, Ombitsvir/paritaprevir/ritonavir also known as Viekirax
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the adult OBV/PTV/RTV formulation: two 12.5 mg ombitasvir /75 mg paritaprevir/50 mg ritonavir tablets taken orally every morning (QD) for 12 weeks (HCV GT1b, GT1a without cirrhosis, and GT4) or 24 weeks (HCV GT1a with compensated cirrhosis).

    Investigational medicinal product name
    Dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks (HCV GT1b, GT1a without cirrhosis) or 24 weeks (HCV GT1a with compensated cirrhosis).

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg tablets were administered orally per local label for 12 weeks (HCV GT1a without cirrhosis and GT4) or 24 weeks (HCV GT1a with compensated cirrhosis).

    Arm title
    		 Mini tablet, 9-11 yr, Part 1
    Arm description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir
    Investigational medicinal product code
    Other name
    ABT-267
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 0.3 mg mini-tablet formulation for 12 weeks, administered orally QD based on body weight.

    Investigational medicinal product name
    Paritaprevir
    Investigational medicinal product code
    Other name
    ABT-450
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 1.0 mg mini-tablet formulation for 12 weeks, administered orally QD based on body weight.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 1.0 mg mini-tablet formulation for 12 weeks, administered orally QD based on body weight.

    Investigational medicinal product name
    Dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 3.08 mg mini-tablet formulation for 12 weeks, administered orally BID based on body weight.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with HCV GT1a received 40 mg/mL oral solution administered per local label for 12 weeks.

    Arm title
    		 Mini tablet, 3-8 yr, Part 1
    Arm description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir
    Investigational medicinal product code
    Other name
    ABT-267
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 0.3 mg mini-tablet formulation for 12 weeks, administered orally QD based on body weight.

    Investigational medicinal product name
    Paritaprevir
    Investigational medicinal product code
    Other name
    ABT-450
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 1.0 mg mini-tablet formulation for 12 weeks, administered orally QD based on body weight.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 1.0 mg mini-tablet formulation for 12 weeks, administered orally QD based on body weight.

    Investigational medicinal product name
    Dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the 3.08 mg mini-tablet formulation for 12 weeks, administered orally BID based on body weight.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with HCV GT1a received 40 mg/mL oral solution administered per local label for 12 weeks.

    Number of subjects in period 1
    		Adult tablet, 12-17 yr, Part 1 Adult tablet, 12-17 yr, Part 2 Mini tablet, 9-11 yr, Part 1 Mini tablet, 3-8 yr, Part 1
    Started
    12
    26
    12
    14
    Completed
    10
    23
    10
    10
    Not completed
    2
    3
    2
    4
         Other, not specified
    -
    -
    1
    -
         Withdrew consent
    1
    -
    -
    1
         Lost to follow-up
    1
    3
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adult tablet, 12-17 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.

    Reporting group title
    Adult tablet, 12-17 yr, Part 2
    Reporting group description
    		 Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.

    Reporting group title
    Mini tablet, 9-11 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.

    Reporting group title
    Mini tablet, 3-8 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.

    Reporting group values
    		 Adult tablet, 12-17 yr, Part 1 Adult tablet, 12-17 yr, Part 2 Mini tablet, 9-11 yr, Part 1 Mini tablet, 3-8 yr, Part 1 Total
    Number of subjects
    		 12 26 12 14 64
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.4 ( 1.73 ) 15.0 ( 1.68 ) 9.8 ( 0.83 ) 4.8 ( 1.67 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 16 6 11 42
        Male
    		 3 10 6 3 22

    End points

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    End points reporting groups
    Reporting group title
    Adult tablet, 12-17 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.

    Reporting group title
    Adult tablet, 12-17 yr, Part 2
    Reporting group description
    		 Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.

    Reporting group title
    Mini tablet, 9-11 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.

    Reporting group title
    Mini tablet, 3-8 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.

    Subject analysis set title
    15 – 29 kg body weight
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment

    Subject analysis set title
    30 – 44 kg body weight
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment

    Subject analysis set title
    ≥ 45 kg body weight
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment

    Subject analysis set title
    Participants in Parts 1 and 2 of the study
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in Parts 1 and 2 who were part of the ITT population (those who received at least one dose of study drug in Part 1 or Part 2)

    Subject analysis set title
    Adult tablet, 12-17 YR, ≥ 45 kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 12-17 years old who received the adult formulation and weighed ≥ 45 kg

    Subject analysis set title
    Mini-tablet, 9-11 YR, 15 to 29 kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 9-11 years old who received the mini-tablet formulation and weighed 15 to 29 kg

    Subject analysis set title
    Mini-tablet, 9-11 YR, 30 to 44 kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 9-11 years old who received the mini-tablet formulation and weighed 30 to 44 kg

    Subject analysis set title
    Mini-tablet, 9-11 YR, ≥ 45 kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 9-11 years old who received the mini-tablet formulation and weighed ≥ 45 kg

    Subject analysis set title
    Mini-tablet, 3-8 YR, 15 to 29 kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 3-8 years old who received the mini-tablet formulation and weighed 15 to 29 kg

    Subject analysis set title
    Mini-tablet total
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants who received the mini-tablet formulation

    Subject analysis set title
    Adult tablet,12-17 YR, ≥ 45 kg, ALT normalization
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 12-17 years old with alanine aminotransferase > upper limit of normal at baseline who received the adult formulation and weighed ≥ 45 kg

    Subject analysis set title
    Mini-tablet, 9-11 YR, 15 to 29 kg, ALT normalization
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 9-11 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 15 to 29 kg

    Subject analysis set title
    Mini-tablet, 9-11 YR, 30 to 44 kg, ALT normalization
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 9-11 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 30 to 44 kg

    Subject analysis set title
    Mini-tablet, 3-8 YR, 15 to 29 kg, ALT normalization
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants age 3-8 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 15 to 29 kg

    Subject analysis set title
    Mini-tablet total, ALT normalization
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation

    Subject analysis set title
    Participants in Parts 1 and 2 of the study, ALT normalization
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants with with alanine aminotransferase > upper limit of normal at baseline

    Primary: Part 1: Maximum plasma concentration (Cmax) of ombitasvir (OBV)

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    End point title
    		 Part 1: Maximum plasma concentration (Cmax) of ombitasvir (OBV) [1]
    End point description
    Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [2]
    9 [3]
    13 [4]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    99.6 ( 27 )
    116 ( 14 )
    83.7 ( 39 )
    Notes
    [2] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [3] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [4] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of ritonavir (RTV)

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    End point title
    		 Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of ritonavir (RTV) [5]
    End point description
    AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [6]
    9 [7]
    12 [8]
    Units: ng•h/mL
        geometric mean (geometric coefficient of variation)
    6570 ( 60 )
    14100 ( 49 )
    8900 ( 37 )
    Notes
    [6] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [7] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [8] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Maximum plasma concentration (Cmax) of paritaprevir (PTV)

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    End point title
    		 Part 1: Maximum plasma concentration (Cmax) of paritaprevir (PTV) [9]
    End point description
    Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [10]
    9 [11]
    13 [12]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    294 ( 152 )
    1540 ( 71 )
    870 ( 125 )
    Notes
    [10] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [11] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [12] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Lowest plasma concentration (Ctrough) of ombitasvir (OBV)

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    End point title
    		 Part 1: Lowest plasma concentration (Ctrough) of ombitasvir (OBV) [13]
    End point description
    Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.
    End point type
    Primary
    End point timeframe
    At Weeks 2 and 8
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [14]
    8 [15]
    12 [16]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Week 2 (n= 12, 8, 12)
    24.7 ( 32 )
    28.2 ( 16 )
    21.8 ( 39 )
        Week 8 (n= 11, 7, 11)
    29.6 ( 78 )
    30.4 ( 24 )
    20.9 ( 58 )
    Notes
    [14] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [15] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [16] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of ombitasvir (OBV)

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    End point title
    		 Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of ombitasvir (OBV) [17]
    End point description
    AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [18]
    8 [19]
    12 [20]
    Units: ng•h/mL
        geometric mean (geometric coefficient of variation)
    1270 ( 26 )
    1490 ( 12 )
    1060 ( 43 )
    Notes
    [18] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [19] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [20] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Maximum plasma concentration (Cmax) of dasabuvir (DSV)

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    End point title
    		 Part 1: Maximum plasma concentration (Cmax) of dasabuvir (DSV) [21]
    End point description
    Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [22]
    9 [23]
    13 [24]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    579 ( 44 )
    830 ( 45 )
    671 ( 48 )
    Notes
    [22] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [23] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [24] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of dasabuvir (DSV)

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    End point title
    		 Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of dasabuvir (DSV) [25]
    End point description
    AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [26]
    9 [27]
    13 [28]
    Units: ng•h/mL
        geometric mean (geometric coefficient of variation)
    3960 ( 44 )
    5960 ( 47 )
    4630 ( 49 )
    Notes
    [26] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [27] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [28] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Lowest plasma concentration (Ctrough) of dasabuvir (DSV)

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    End point title
    		 Part 1: Lowest plasma concentration (Ctrough) of dasabuvir (DSV) [29]
    End point description
    Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.
    End point type
    Primary
    End point timeframe
    At Weeks 2 and 8
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [30]
    9 [31]
    13 [32]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Week 2 (n= 12, 9, 13)
    110 ( 57 )
    215 ( 54 )
    165 ( 56 )
        Week 8 (n= 12, 7 ,11)
    168 ( 82 )
    264 ( 65 )
    191 ( 60 )
    Notes
    [30] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [31] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [32] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of paritaprevir (PTV)

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    End point title
    		 Part 1: Concentration of drug in blood plasma over time [Area under the curve (AUC)] of paritaprevir (PTV) [33]
    End point description
    AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [34]
    8 [35]
    12 [36]
    Units: ng•h/mL
        geometric mean (geometric coefficient of variation)
    2180 ( 136 )
    8640 ( 90 )
    5770 ( 152 )
    Notes
    [34] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [35] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [36] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Maximum plasma concentration (Cmax) of ritonavir (RTV)

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    End point title
    		 Part 1: Maximum plasma concentration (Cmax) of ritonavir (RTV) [37]
    End point description
    Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
    End point type
    Primary
    End point timeframe
    At Week 2
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [38]
    9 [39]
    13 [40]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    1090 ( 67 )
    1830 ( 42 )
    1180 ( 35 )
    Notes
    [38] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [39] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [40] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Lowest plasma concentration (Ctrough) of paritaprevir (PTV)

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    End point title
    		 Part 1: Lowest plasma concentration (Ctrough) of paritaprevir (PTV) [41]
    End point description
    Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.
    End point type
    Primary
    End point timeframe
    At Weeks 2 and 8
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [42]
    8 [43]
    12 [44]
    Units: : ng/mL
    geometric mean (geometric coefficient of variation)
        Week 2 (n= 12, 8, 12)
    9.86 ( 113 )
    16.1 ( 112 )
    18.0 ( 78 )
        Week 8 (n= 12, 7 ,11)
    17.3 ( 136 )
    18.4 ( 89 )
    23.5 ( 86 )
    Notes
    [42] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [43] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    [44] - ITT: all subjects who received at least one dose of study drug in Part 1 with available data
    No statistical analyses for this end point

    Primary: Part 1: Lowest plasma concentration (Ctrough) of ritonavir (RTV)

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    End point title
    		 Part 1: Lowest plasma concentration (Ctrough) of ritonavir (RTV) [45]
    End point description
    Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.
    End point type
    Primary
    End point timeframe
    At Weeks 2 and 8
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analyses are planned for pharmacokinetic endpoints
    End point values
    		 15 – 29 kg body weight 30 – 44 kg body weight ≥ 45 kg body weight
    Number of subjects analysed
    12 [46]
    9 [47]
    12 [48]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Week 2 (n= 12, 9, 12)
    16.1 ( 72 )
    32.1 ( 63 )
    29.8 ( 54 )
        Week 8 (n= 12, 7 ,11)
    91.8 ( 268 )
    38.1 ( 112 )
    58.2 ( 138 )
    Notes
    [46] - The statistical analysis data per protocol are presented in the Endpoint Data Table.
    [47] - The statistical analysis data per protocol are presented in the Endpoint Data Table.
    [48] - The statistical analysis data per protocol are presented in the Endpoint Data Table.
    No statistical analyses for this end point

    Primary: Parts 1 and 2: Percentage of participants with sustained virologic response 12 weeks after the last actual dose of study drug (SVR12)

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    End point title
    		 Parts 1 and 2: Percentage of participants with sustained virologic response 12 weeks after the last actual dose of study drug (SVR12) [49]
    End point description
    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
    End point type
    Primary
    End point timeframe
    12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: According to the Highlights of Prescribing Information of PEGASYS, the SVR24 rate was 47% among 45 treatment-naïve pediatric participants with HCV GT1 in the NV17424 trial. To show that the DAA regimen is superior to this current standard of care by 20%, the lower bound of the 2-sided 95% confidence interval of the SVR12 rate across all participants in the study must be greater than 67%. The Wilson's score method was used to calculate the confidence interval.
    End point values
    		 Participants in Parts 1 and 2 of the study
    Number of subjects analysed
    64 [50]
    Units: percentage of participants
        number (confidence interval 95%)
    98.4 (91.7 to 99.7)
    Notes
    [50] - ITT population: missing data after backwards imputation = nonresponders
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of participants with sustained virologic response 12 weeks after the last actual dose of study drug (SVR12) summarized by formulation, age and weight group, and across all subjects on the adult formulations

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    End point title
    		 Parts 1 and 2: Percentage of participants with sustained virologic response 12 weeks after the last actual dose of study drug (SVR12) summarized by formulation, age and weight group, and across all subjects on the adult formulations
    End point description
    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
    End point type
    Secondary
    End point timeframe
    12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
    End point values
    		 Adult tablet, 12-17 YR, ≥ 45 kg Mini-tablet, 9-11 YR, 15 to 29 kg Mini-tablet, 9-11 YR, 30 to 44 kg Mini-tablet, 9-11 YR, ≥ 45 kg Mini-tablet, 3-8 YR, 15 to 29 kg Mini-tablet total
    Number of subjects analysed
    38 [51]
    1 [52]
    9 [53]
    2 [54]
    14 [55]
    26 [56]
    Units: percentage of participants
        number (confidence interval 95%)
    100 (90.8 to 100.0)
    100 (20.7 to 100.0)
    100 (70.1 to 100.0)
    100 (34.2 to 100.0)
    92.9 (68.5 to 98.7)
    96.2 (81.1 to 99.3)
    Notes
    [51] - ITT population: missing data after backwards imputation = nonresponders
    [52] - ITT population: missing data after backwards imputation = nonresponders
    [53] - ITT population: missing data after backwards imputation = nonresponders
    [54] - ITT population: missing data after backwards imputation = nonresponders
    [55] - ITT population: missing data after backwards imputation = nonresponders
    [56] - ITT population: missing data after backwards imputation = nonresponders
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of participants with sustained virologic response 24 weeks after the last actual dose of study drug (SVR24), summarized by formulation, age and weight group, across all subjects, and across all subjects on the adult formulations

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    End point title
    		 Parts 1 and 2: Percentage of participants with sustained virologic response 24 weeks after the last actual dose of study drug (SVR24), summarized by formulation, age and weight group, across all subjects, and across all subjects on the adult formulations
    End point description
    SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug.
    End point type
    Secondary
    End point timeframe
    24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)
    End point values
    		 Participants in Parts 1 and 2 of the study Adult tablet, 12-17 YR, ≥ 45 kg Mini-tablet, 9-11 YR, 15 to 29 kg Mini-tablet, 9-11 YR, 30 to 44 kg Mini-tablet, 9-11 YR, ≥ 45 kg Mini-tablet, 3-8 YR, 15 to 29 kg Mini-tablet total
    Number of subjects analysed
    64 [57]
    38 [58]
    1 [59]
    9 [60]
    2 [61]
    14 [62]
    26 [63]
    Units: percentage of participants
        number (confidence interval 95%)
    96.9 (89.3 to 99.1)
    100 (90.8 to 100.0)
    100.0 (20.7 to 100.0)
    88.9 (56.5 to 98.0)
    100.0 (34.2 to 100.0)
    92.9 (68.5 to 98.7)
    92.3 (75.9 to 97.9)
    Notes
    [57] - ITT population: missing data after backwards imputation = nonresponders
    [58] - ITT population: missing data after backwards imputation = nonresponders
    [59] - ITT population: missing data after backwards imputation = nonresponders
    [60] - ITT population: missing data after backwards imputation = nonresponders
    [61] - ITT population: missing data after backwards imputation = nonresponders
    [62] - ITT population: missing data after backwards imputation = nonresponders
    [63] - ITT population: missing data after backwards imputation = nonresponders
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of participants with alanine aminotransferase (ALT) normalization during treatment by formulation, age and weight group, across all subjects, and across all subjects on the adult formulations

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    End point title
    		 Parts 1 and 2: Percentage of participants with alanine aminotransferase (ALT) normalization during treatment by formulation, age and weight group, across all subjects, and across all subjects on the adult formulations
    End point description
    Alanine aminotransferase (ALT) normalization during treatment is defined as ALT ≤ the upper limit of normal (ULN) at the final treatment visit for participants with ALT > ULN at baseline.
    End point type
    Secondary
    End point timeframe
    12 or 24 weeks after starting study drug, depending on treatment duration
    End point values
    		 Adult tablet,12-17 YR, ≥ 45 kg, ALT normalization Mini-tablet, 9-11 YR, 15 to 29 kg, ALT normalization Mini-tablet, 9-11 YR, 30 to 44 kg, ALT normalization Mini-tablet, 3-8 YR, 15 to 29 kg, ALT normalization Mini-tablet total, ALT normalization Participants in Parts 1 and 2 of the study, ALT normalization
    Number of subjects analysed
    24 [64]
    1 [65]
    5 [66]
    10 [67]
    16 [68]
    40 [69]
    Units: percentage of participants
        number (confidence interval 95%)
    87.5 (69.0 to 95.7)
    100 (20.7 to 100.0)
    100 (56.6 to 100.0)
    80.0 (49.0 to 94.3)
    87.5 (64.0 to 96.5)
    87.5 (73.9 to 94.5)
    Notes
    [64] - ITT population with ALT > ULN at baseline and available on-treatment ALT data
    [65] - ITT population with ALT > ULN at baseline and available on-treatment ALT data
    [66] - ITT population with ALT > ULN at baseline and available on-treatment ALT data
    [67] - ITT population with ALT > ULN at baseline and available on-treatment ALT data
    [68] - ITT population with ALT > ULN at baseline and available on-treatment ALT data
    [69] - ITT population with ALT > ULN at baseline and available on-treatment ALT data
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) collected from 1st dose of study drug until 30 d after last dose, up to 37 wks. SAEs and protocol-related nonserious AEs were collected from the time the subject signed consent
    Adverse event reporting additional description
    TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Adult tablet, 12-17 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.

    Reporting group title
    Adult tablet, 12-17 yr, Part 2
    Reporting group description
    		 Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.

    Reporting group title
    Adult tablet, 12-17 yr, Total
    Reporting group description
    		 Participants age 12-17 years old who received at least one dose of the adult formulation

    Reporting group title
    Mini tablet, 9-11 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.

    Reporting group title
    Mini tablet, 3-8 yr, Part 1
    Reporting group description
    		 Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.

    Reporting group title
    Mini tablet, Total
    Reporting group description
    		 Participants who received at least one dose of the mini-tablet formulation

    Reporting group title
    All participants, Total
    Reporting group description
    		 All participants who received at least one dose of study drug in Part 1 or Part 2

    Serious adverse events
    		 Adult tablet, 12-17 yr, Part 1 Adult tablet, 12-17 yr, Part 2 Adult tablet, 12-17 yr, Total Mini tablet, 9-11 yr, Part 1 Mini tablet, 3-8 yr, Part 1 Mini tablet, Total All participants, Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    LEUKOPENIA
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adult tablet, 12-17 yr, Part 1 Adult tablet, 12-17 yr, Part 2 Adult tablet, 12-17 yr, Total Mini tablet, 9-11 yr, Part 1 Mini tablet, 3-8 yr, Part 1 Mini tablet, Total All participants, Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    17 / 26 (65.38%)
    28 / 38 (73.68%)
    12 / 12 (100.00%)
    9 / 14 (64.29%)
    21 / 26 (80.77%)
    49 / 64 (76.56%)
    General disorders and administration site conditions
    CHEST DISCOMFORT
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    CHEST PAIN
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 26 (3.85%)
    2 / 38 (5.26%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    2
    CHILLS
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    FATIGUE
         subjects affected / exposed
    2 / 12 (16.67%)
    5 / 26 (19.23%)
    7 / 38 (18.42%)
    5 / 12 (41.67%)
    1 / 14 (7.14%)
    6 / 26 (23.08%)
    13 / 64 (20.31%)
         occurrences all number
    2
    5
    7
    5
    1
    6
    13
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    PAIN
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    2 / 26 (7.69%)
    2 / 64 (3.13%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    2
    PYREXIA
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 26 (3.85%)
    3 / 38 (7.89%)
    3 / 12 (25.00%)
    2 / 14 (14.29%)
    5 / 26 (19.23%)
    8 / 64 (12.50%)
         occurrences all number
    2
    1
    3
    4
    2
    6
    9
    VESSEL PUNCTURE SITE PAIN
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    Immune system disorders
    SEASONAL ALLERGY
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    2 / 12 (16.67%)
    0 / 14 (0.00%)
    2 / 26 (7.69%)
    2 / 64 (3.13%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    2
    Reproductive system and breast disorders
    DYSMENORRHOEA
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 26 (11.54%)
    3 / 38 (7.89%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    3
    3
    0
    0
    0
    3
    PRURITUS GENITAL
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    VAGINAL DISCHARGE
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 26 (7.69%)
    2 / 38 (5.26%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    2 / 12 (16.67%)
    2 / 14 (14.29%)
    4 / 26 (15.38%)
    4 / 64 (6.25%)
         occurrences all number
    0
    0
    0
    2
    2
    4
    4
    EPISTAXIS
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    0
    3
    3
    1
    0
    1
    4
    NASAL CONGESTION
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 26 (3.85%)
    3 / 38 (7.89%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    2
    1
    3
    0
    0
    0
    3
    RHINORRHOEA
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    2 / 12 (16.67%)
    0 / 14 (0.00%)
    2 / 26 (7.69%)
    2 / 64 (3.13%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    2
    SNEEZING
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 26 (0.00%)
    2 / 38 (5.26%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    2
    BEHAVIOURAL INSOMNIA OF CHILDHOOD
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    DEPRESSION
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    MOOD SWINGS
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    NIGHTMARE
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    SLEEP TERROR
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    SUICIDAL IDEATION
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Investigations
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    ELECTROCARDIOGRAM ABNORMAL
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    ELECTROCARDIOGRAM CHANGE
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Injury, poisoning and procedural complications
    ARTHROPOD BITE
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Cardiac disorders
    ATRIOVENTRICULAR BLOCK FIRST DEGREE
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 26 (7.69%)
    2 / 38 (5.26%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    2
    HEADACHE
         subjects affected / exposed
    3 / 12 (25.00%)
    5 / 26 (19.23%)
    8 / 38 (21.05%)
    5 / 12 (41.67%)
    2 / 14 (14.29%)
    7 / 26 (26.92%)
    15 / 64 (23.44%)
         occurrences all number
    3
    5
    8
    6
    2
    8
    16
    PARAESTHESIA
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    2
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    2
    0
    2
    1
    0
    1
    3
    HAEMOLYSIS
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    LYMPHOPENIA
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    NEUTROPENIA
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 26 (0.00%)
    2 / 38 (5.26%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    3 / 64 (4.69%)
         occurrences all number
    2
    0
    2
    1
    0
    1
    3
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    2 / 12 (16.67%)
    0 / 14 (0.00%)
    2 / 26 (7.69%)
    3 / 64 (4.69%)
         occurrences all number
    0
    1
    1
    2
    0
    2
    3
    CONSTIPATION
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    2
    DIARRHOEA
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    3 / 12 (25.00%)
    0 / 14 (0.00%)
    3 / 26 (11.54%)
    4 / 64 (6.25%)
         occurrences all number
    0
    1
    1
    3
    0
    3
    4
    FLATULENCE
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    2 / 12 (16.67%)
    0 / 14 (0.00%)
    2 / 26 (7.69%)
    2 / 64 (3.13%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    2
    GASTRITIS
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    2
    LIP ULCERATION
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    NAUSEA
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 26 (0.00%)
    3 / 38 (7.89%)
    3 / 12 (25.00%)
    1 / 14 (7.14%)
    4 / 26 (15.38%)
    7 / 64 (10.94%)
         occurrences all number
    3
    0
    3
    3
    1
    4
    7
    VOMITING
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    4 / 12 (33.33%)
    1 / 14 (7.14%)
    5 / 26 (19.23%)
    6 / 64 (9.38%)
         occurrences all number
    0
    1
    1
    4
    1
    5
    6
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    Skin and subcutaneous tissue disorders
    ECZEMA
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    PRURITUS
         subjects affected / exposed
    1 / 12 (8.33%)
    4 / 26 (15.38%)
    5 / 38 (13.16%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    2 / 26 (7.69%)
    7 / 64 (10.94%)
         occurrences all number
    1
    4
    5
    1
    1
    2
    7
    RASH
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    1
    0
    1
    1
    0
    1
    2
    RASH PAPULAR
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    BACK PAIN
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 26 (3.85%)
    2 / 38 (5.26%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    2
    NECK PAIN
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 26 (3.85%)
    2 / 38 (5.26%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    2
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    PAIN IN JAW
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    Infections and infestations
    ACUTE SINUSITIS
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    GASTROENTERITIS
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    2
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    2 / 14 (14.29%)
    2 / 26 (7.69%)
    2 / 64 (3.13%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    2
    IMPETIGO
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    2
    INFLUENZA
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 26 (3.85%)
    1 / 38 (2.63%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    2
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 12 (8.33%)
    4 / 26 (15.38%)
    5 / 38 (13.16%)
    2 / 12 (16.67%)
    1 / 14 (7.14%)
    3 / 26 (11.54%)
    8 / 64 (12.50%)
         occurrences all number
    1
    5
    6
    2
    2
    4
    10
    ORAL HERPES
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    OTITIS MEDIA
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    PHARYNGITIS STREPTOCOCCAL
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    2 / 64 (3.13%)
         occurrences all number
    1
    0
    1
    1
    0
    1
    2
    SINUSITIS
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 26 (0.00%)
    2 / 38 (5.26%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    2
    STREPTOCOCCAL INFECTION
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    TRACHEITIS
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 26 (0.00%)
    1 / 38 (2.63%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 26 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 26 (7.69%)
    4 / 38 (10.53%)
    1 / 12 (8.33%)
    3 / 14 (21.43%)
    4 / 26 (15.38%)
    8 / 64 (12.50%)
         occurrences all number
    3
    3
    6
    1
    3
    4
    10
    VIRAL INFECTION
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    2 / 26 (7.69%)
    2 / 64 (3.13%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    2
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 26 (3.85%)
    2 / 38 (5.26%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    3 / 64 (4.69%)
         occurrences all number
    1
    1
    2
    1
    0
    1
    3
    HYPERTRIGLYCERIDAEMIA
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    INCREASED APPETITE
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 26 (0.00%)
    0 / 38 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 26 (3.85%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2015
    Amendment 1 • Modified language regarding fibrosis assessments at screening • Added longitudinal FibroTest to study procedures • Added an additional virologic failure criterion • Edited ALT monitoring and management parameters • Added information regarding drug storage • Added Medical Complaint language • Added an additional efficacy endpoint in Part 2 of the study
    07 Jul 2016
    Amendment 2 • Reduced the sample size in Part 2 • Changed treatment of GT1b-infected patients with compensated cirrhosis to OBV/PTV/RTV and DSV without RBV for 12 weeks • Changed treatment of GT4-infected patients with compensated cirrhosis to OBV/PTV/RTV and RBV for 12 weeks • Updated contraceptive language in the protocol • Added the guidelines that were followed regarding total blood loss per patient during the study • Provided additional details for alternate management for subjects meeting virologic failure criteria • Incorporated Administrative Change 1.0 to update the DSV strength concentration
    21 Aug 2017
    Amendment 3 • Removed pellets formulation from the study, and changed all endpoints to remove the pellet formulation • Removed aspartate aminotransferase-to-platelet ratio index (APRI) from study procedures • Updated contraceptive language in the protocol • Updated virologic failure criteria • Reduced the duration of LTFU Period

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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