Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Exploratory Study to Evaluate the Kinetics of Viral Load Decline with Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy with Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment-Naïve Adults with Genotype 1a Chronic Hepatitis C Virus (HCV) Infection

    Summary
    EudraCT number
    		 2014-001478-32
    Trial protocol
    		 FR  
    Global end of trial date
    06 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2017
    First version publication date
    15 Oct 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M14-242
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02493855
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abbvie Deutschland GmbH & Co.KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 011 800-633-9110, eu-clinical-trials@abbvie.com
    Scientific contact
    Emily Dumas, PhD, AbbVie, emily.dumas@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.
    Protection of trial subjects
    All subjects entering the study had to sign an informed consent that was explained to them and questions encouraged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 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
    United States: 29
    Country: Number of subjects enrolled
    France: 17
    Worldwide total number of subjects
    46
    EEA total number of subjects
    17
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    46
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at one clinic in France and one clinic in the United States. Participants were treatment-naïve adults with hepatitis C virus (HCV) genotype (GT)1a infection without cirrhosis.

    Pre-assignment
    Screening details
    		 Participants were randomized to Arms A or B in a 1:1 ratio first, and once those arms fully enrolled, Arm C was enrolled. Randomization to Arms A and B was stratified by site.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Ribavirin Full Dose for Last 10 Weeks
    Arm description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/ABT-450/Ritonavir
    Investigational medicinal product code
    Other name
    ABT-267/ABT-450/ritonavir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir/ABT-450/ritonavir combination tablets taken once daily

    Investigational medicinal product name
    Dasabuvir
    Investigational medicinal product code
    ABT-333
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasabuvir 250 mg tablets taken twice daily

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg tablets: subjects weighing < 75 kg received 2 tablets in the morning and 3 tablets in the evening (1000 mg total daily dose); subjects weighing ≥ 75 kg received 3 tablets in the morning and 3 tablets in the evening (1200 mg total daily dose).

    Arm title
    		 Arm B: Ribavirin Full Dose for 12 Weeks
    Arm description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/ABT-450/Ritonavir
    Investigational medicinal product code
    Other name
    ABT-267/ABT-450/ritonavir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir/ABT-450/ritonavir combination tablets taken once daily

    Investigational medicinal product name
    Dasabuvir
    Investigational medicinal product code
    ABT-333
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasabuvir 250 mg tablets taken twice daily

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg tablets: subjects weighing < 75 kg received 2 tablets in the morning and 3 tablets in the evening (1000 mg total daily dose); subjects weighing ≥ 75 kg received 3 tablets in the morning and 3 tablets in the evening (1200 mg total daily dose).

    Arm title
    		 Arm C: Ribavirin Low-dose for 12 Weeks
    Arm description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/ABT-450/Ritonavir
    Investigational medicinal product code
    Other name
    ABT-267/ABT-450/ritonavir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir/ABT-450/ritonavir combination tablets taken once daily

    Investigational medicinal product name
    Dasabuvir
    Investigational medicinal product code
    ABT-333
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasabuvir 250 mg tablets taken twice daily

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg tablets taken orally as 3 tablets once daily (total 600 mg QD)

    Number of subjects in period 1
    		Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
    Started
    21
    19
    6
    Completed
    19
    18
    6
    Not completed
    2
    1
    0
         Consent withdrawn by subject
    1
    -
    -
         Non-compliance
    1
    -
    -
         Adverse event
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Ribavirin Full Dose for Last 10 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.

    Reporting group title
    Arm B: Ribavirin Full Dose for 12 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.

    Reporting group title
    Arm C: Ribavirin Low-dose for 12 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.

    Reporting group values
    		 Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks Total
    Number of subjects
    		 21 19 6 46
    Age categorical
    Units: Subjects
        < 55 years
    		 17 14 5 36
        ≥ 55 - 65 years
    		 4 5 1 10
        ≥ 65 years
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.9 ± 11.96 46 ± 12.78 36.7 ± 15.79 -
    Gender categorical
    Units: Subjects
        Female
    		 11 12 4 27
        Male
    		 10 7 2 19
    Race
    Units: Subjects
        White
    		 16 14 4 34
        Black or African American
    		 4 3 1 8
        Asian
    		 0 0 0 0
        American Indian or Alaskan Native
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Multi-race
    		 1 2 1 4

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm A: Ribavirin Full Dose for Last 10 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.

    Reporting group title
    Arm B: Ribavirin Full Dose for 12 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.

    Reporting group title
    Arm C: Ribavirin Low-dose for 12 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.

    Primary: Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment

    		 Close Top of page
    End point title
    		 Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment
    End point description
    HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm. Participants with evaluable HCV RNA to calculate the slope of the second phase were included in the analysis. Three participants were excluded due to algorithm non-convergence in the non-linear modeling process.
    End point type
    Primary
    End point timeframe
    From Week 0 to Week 2
    End point values
    		 Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
    Number of subjects analysed
    20
    17
    6
    Units: 1/day
        median (full range (min-max))
    0.0036 (0.0006 to 0.0128)
    0.0046 (-0.0003 to 0.0155)
    0.0051 (0.0031 to 0.0076)
    Statistical analysis title
    		 Comparison of Slope
    Statistical analysis description
    This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.
    Comparison groups
    Arm B: Ribavirin Full Dose for 12 Weeks v Arm A: Ribavirin Full Dose for Last 10 Weeks
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.311
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 Comparison of Slope
    Statistical analysis description
    This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.
    Comparison groups
    Arm B: Ribavirin Full Dose for 12 Weeks v Arm C: Ribavirin Low-dose for 12 Weeks
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.561
    Method
    		 Wilcoxon Rank Sum Test
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until 30 days after last dose; up to 16 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Arm A: Ribavirin Full Dose for Last 10 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.

    Reporting group title
    Arm B: Ribavirin Full Dose for 12 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.

    Reporting group title
    Arm C: Ribavirin Low-dose for 12 Weeks
    Reporting group description
    		 Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.

    Serious adverse events
    		 Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Dependence
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A: Ribavirin Full Dose for Last 10 Weeks Arm B: Ribavirin Full Dose for 12 Weeks Arm C: Ribavirin Low-dose for 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 21 (80.95%)
    16 / 19 (84.21%)
    6 / 6 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 19 (15.79%)
    0 / 6 (0.00%)
         occurrences all number
    3
    3
    0
    Fatigue
         subjects affected / exposed
    5 / 21 (23.81%)
    7 / 19 (36.84%)
    2 / 6 (33.33%)
         occurrences all number
    5
    7
    2
    Feeling Abnormal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Polymenorrhoea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    1
    Respiratory Tract Congestion
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus Congestion
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Confusional State
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Depressed Mood
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Depression
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    3
    2
    0
    Emotional Distress
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Insomnia
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 19 (15.79%)
    0 / 6 (0.00%)
         occurrences all number
    3
    3
    0
    Irritability
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Mood Swings
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Sleep Disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Investigations
    Activated Partial Thromboplastin Time Prolonged
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Body Temperature Fluctuation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Glucose Urine Present
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin Decreased
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 19 (15.79%)
    0 / 6 (0.00%)
         occurrences all number
    2
    4
    0
    International Normalised Ratio Increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Prothrombin Level Increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Limb Injury
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Procedural Headache
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural Pain
         subjects affected / exposed
    7 / 21 (33.33%)
    5 / 19 (26.32%)
    5 / 6 (83.33%)
         occurrences all number
    9
    6
    10
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Headache
         subjects affected / exposed
    4 / 21 (19.05%)
    4 / 19 (21.05%)
    0 / 6 (0.00%)
         occurrences all number
    4
    5
    0
    Memory Impairment
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 19 (15.79%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    Migraine
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 21 (19.05%)
    4 / 19 (21.05%)
    2 / 6 (33.33%)
         occurrences all number
    6
    7
    2
    Increased Tendency To Bruise
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal Pain
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 19 (15.79%)
    1 / 6 (16.67%)
         occurrences all number
    4
    4
    1
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Dry Mouth
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    2 / 6 (33.33%)
         occurrences all number
    1
    1
    2
    Dyspepsia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
    3 / 6 (50.00%)
         occurrences all number
    0
    2
    3
    Haematochezia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 19 (15.79%)
    2 / 6 (33.33%)
         occurrences all number
    4
    3
    2
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    5
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    4
    0
    5
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Angioedema
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis Contact
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Dry Skin
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Pruritus
         subjects affected / exposed
    3 / 21 (14.29%)
    6 / 19 (31.58%)
    1 / 6 (16.67%)
         occurrences all number
    4
    6
    1
    Rash
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    2 / 6 (33.33%)
         occurrences all number
    0
    1
    2
    Rash Generalised
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Back Pain
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    2 / 6 (33.33%)
         occurrences all number
    3
    1
    2
    Flank Pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Muscle Tightness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal Pain
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal Skin Infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Oral Candidiasis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Hypermagnesaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2015
    The purpose of this amendment was as follows: ● Update Introduction to remove language detailing effects of ABT-450/ritonavir, ABT-267 (and its major, inactive human metabolites) and ABT-333 on embryo-fetal development. ● Update Introduction to refer Investigators to locally approved labels for preclinical toxicology (including reproductive and developmental toxicology), metabolism, pharmacokinetics and drug-drug interactions in countries that have received marketing approval. ● Decrease the duration of RBV-free treatment in Arm A from 4 to 2 weeks. ● Update Contraindicated Medication list in Synopsis and Exclusion 3 (Amendment 1, Table 4) and refer Investigators to local labels for the AbbVie product containing the regimen for this study. ● Modify the time points of FNA of the liver and peripheral blood mononuclear cell (PBMC) samples in subjects at the specified site in the United States. ● Clarify that virologic failures will be offered retreatment with 3-DAA + sofosbuvir + RBV. ● Address inconsistencies throughout the protocol.
    11 Oct 2016
    The purpose of this amendment was to accomplish the following: ● Clarify that virologic failures will be offered retreatment with ABT-493/ABT-530 + sofosbuvir + RBV. ● Update Section 6.0, Complaints, to incorporate new protocol template language. ● Update Section 5.3.1, Table 5, Activities Table, and Section 6.1.4, Adverse Event Collection Period, to incorporate collection of serious adverse events after 30 days following the last dose of study drug. ● To incorporate administrative changes made throughout for clarity as well as to update study personnel titles, study contact information, and to document the new study Medical Director.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 10:01:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA