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    Clinical Trial Results:
    An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)

    Summary
    EudraCT number
    2015-003370-33
    Trial protocol
    DE   GB   ES   IT  
    Global end of trial date
    01 Dec 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Dec 2017
    First version publication date
    02 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-684
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02582632
    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
    Daniel E. Cohen, MD, AbbVie, 001 847-938-1494, daniel.cohen@abbvie.com
    Scientific contact
    Daniel E. Cohen, MD, AbbVie, 001 847-938-1494, daniel.cohen@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
    01 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the efficacy (the percentage of subjects achieving SVR12 [HCV ribonucleic acid {RNA} < lower limit of quantification {LLOQ} 12 weeks following treatment]) of coformulated ombitasvir/paritaprevir/ritonavir and dasabuvir for 8 weeks in treatment-naïve adults with HCV GT1b infection without cirrhosis.
    Protection of trial subjects
    Participant and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Nov 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
    Canada: 17
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    France: 27
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Israel: 21
    Country: Number of subjects enrolled
    Italy: 22
    Country: Number of subjects enrolled
    Spain: 27
    Worldwide total number of subjects
    166
    EEA total number of subjects
    111
    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)
    137
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Eligible subjects had up to 35 days following the Screening Visit to enroll into the study.

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

    Arms
    Arm title
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Arm description
    ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Ombitasvir/Paritaprevir/Ritonavir 12.5 mg/75 mg/50 mg Film-Coated Tablets
    Investigational medicinal product code
    Other name
    ABT-267/ABT-450/r, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir/paritaprevir/ritonavir will be taken orally as 2 tablets once daily which corresponds to a 25 mg ombitasvir/150 mg paritaprevir/100 mg ritonavir dose once daily.

    Investigational medicinal product name
    Dasabuvir 250 mg Film-Coated Tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasabuvir will be taken orally as 1 tablet twice daily, which corresponds to a 250 mg dose twice daily.

    Number of subjects in period 1
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Started
    166
    Completed
    165
    Not completed
    1
         Not specified
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Reporting group description
    ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks

    Reporting group values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Total
    Number of subjects
    166 166
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.3 ± 13.42 -
    Gender categorical
    Units: Subjects
        Female
    94 94
        Male
    72 72

    End points

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    End points reporting groups
    Reporting group title
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Reporting group description
    ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks

    Primary: Percentage of Subjects Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

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    End point title
    Percentage of Subjects Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [1]
    End point description
    SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. Intent to Treat population: all enrolled subjects who received at least 1 dose of study drug. Flanking imputation.
    End point type
    Primary
    End point timeframe
    12 weeks after the last actual dose of study drug
    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: Descriptive statistics and confidence interval are presented, per protocol.
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    166
    Units: percentage of subjects
        number (confidence interval 95%)
    97.6 (95.3 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With On-Treatment Virologic Failure During Treatment Period

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    End point title
    Percentage of Subjects With On-Treatment Virologic Failure During Treatment Period
    End point description
    On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution. Intent to Treat population: all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks while on treatment
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    166
    Units: percentage of subjects
        number (confidence interval 95%)
    0.6 (0.0 to 1.8)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Post-Treatment Relapse12

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    End point title
    Percentage of Subjects With Post-Treatment Relapse12
    End point description
    Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among subjects with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for subjects who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. Intent to Treat population: all enrolled participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks after last dose of study drug
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    163
    Units: percentage of subjects
        number (confidence interval 95%)
    1.2 (0.0 to 2.9)
    No statistical analyses for this end point

    Secondary: Percentage of Female Subjects Responding With SVR12

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    End point title
    Percentage of Female Subjects Responding With SVR12
    End point description
    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. Intent to Treat population: all enrolled female subjects who received at least 1 dose of study drug. Flanking imputation.
    End point type
    Secondary
    End point timeframe
    12 weeks after the last actual dose of study drug
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    94
    Units: percentage of subjects
        number (confidence interval 95%)
    97.9 (95.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12

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    End point title
    Percentage of Subjects With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12
    End point description
    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. Intent to Treat population: all enrolled subjects who received at least 1 dose of study drug and with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks after the last actual dose of study drug
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    154
    Units: percentage of subjects
        number (confidence interval 95%)
    98.1 (95.9 to 100.0)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Who Achieve SVR12: mITT-GT Population

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    End point title
    Percentage of Subjects Who Achieve SVR12: mITT-GT Population
    End point description
    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. The modified ITT (mITT)-GT population includes subjects who received at least 1 dose of study drug but excludes the subjects who do not have HCV GT1b infection. Flanking imputation.
    End point type
    Other pre-specified
    End point timeframe
    12 weeks after the last actual dose of study drug
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    163
    Units: percentage of subjects
        number (confidence interval 95%)
    98.2 (96.1 to 100.0)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population

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    End point title
    Percentage of Subjects With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population
    End point description
    On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method. The mITT-GT population includes subjects who received at least 1 dose of study drug but excludes the subjects who do not have HCV GT1b infection.
    End point type
    Other pre-specified
    End point timeframe
    Up to 8 weeks while on treatment
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    163
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 2.3)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With Post-Treatment Relapse12: mITT-GT Population

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    End point title
    Percentage of Subjects With Post-Treatment Relapse12: mITT-GT Population
    End point description
    Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among subjects with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for subjects who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. Subjects who did not complete treatment, had no post treatment data, or had HCV RNA ≥ LLOQ at Final Treatment Visit were not included.
    End point type
    Other pre-specified
    End point timeframe
    Up to 12 weeks after last dose of study drug
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    161 [2]
    Units: percentage of subjects
        number (confidence interval 95%)
    1.2 (0.0 to 3.0)
    Notes
    [2] - mITT population
    No statistical analyses for this end point

    Other pre-specified: Percentage of Female Subjects Responding With SVR12: mITT-GT Population

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    End point title
    Percentage of Female Subjects Responding With SVR12: mITT-GT Population
    End point description
    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. The mITT-GT population includes subjects who received at least 1 dose of study drug but excludes the subjects who do not have HCV GT1b infection; female subjects. Flanking imputation.
    End point type
    Other pre-specified
    End point timeframe
    12 weeks after the last actual dose of study drug
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    93
    Units: percentage of subjects
        number (confidence interval 95%)
    97.8 (94.9 to 100.0)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population

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    End point title
    Percentage of Subjects With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population
    End point description
    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. The mITT-GT population includes subjects who received at least 1 dose of study drug but excludes the subjects who do not have HCV GT1b infection; subjects with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.
    End point type
    Other pre-specified
    End point timeframe
    Baseline and 12 weeks after the last actual dose of study drug
    End point values
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Number of subjects analysed
    151
    Units: percentage of subjects
        number (confidence interval 95%)
    98.7 (96.9 to 100.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks); SAEs were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug)
    Adverse event reporting additional description
    A TEAE is defined as any AE from the first dose of study drug to 30 days after the last dose.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Reporting group description
    ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks

    Serious adverse events
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 166 (1.20%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 166 (42.17%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    35 / 166 (21.08%)
         occurrences all number
    36
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    11
    Fatigue
         subjects affected / exposed
    28 / 166 (16.87%)
         occurrences all number
    30
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    11 / 166 (6.63%)
         occurrences all number
    12
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    14 / 166 (8.43%)
         occurrences all number
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 166 (8.43%)
         occurrences all number
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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    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.

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