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   43927   clinical trials with a EudraCT protocol, of which   7307   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:
    Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir with Ribavirin (RBV) in Adult Patients with GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma

    Summary
    EudraCT number
    2015-001049-10
    Trial protocol
    ES  
    Global end of trial date
    29 Dec 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    05 Apr 2018
    First version publication date
    14 Oct 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Correction in secondary outcome measure time frame.

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    M14-726
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02504099
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Marisol Martinez, MD, AbbVie, Marisol.Martinez@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
    29 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jul 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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    0
    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)
    2
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was stopped due to low enrollment.

    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
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Arm description
    OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
    Arm type
    Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet; ombitasvir coformulated with paritaprevir and ritonavir

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, dasabuvir also known as ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet

    Number of subjects in period 1
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Started
    3
    Completed
    3

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Reporting group description
    OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.

    Reporting group values
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks Total
    Number of subjects
    3 3
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.3 ± 1.53 -
    Gender categorical
    Units: Subjects
        Female
    1 1
        Male
    2 2

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Reporting group description
    OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.

    Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

    Close Top of page
    End point title
    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [1]
    End point description
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after flanking imputation were imputed as nonresponders.
    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: The study was stopped due to low enrollment; analyses of efficacy end points were not performed.
    End point values
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Number of subjects analysed
    0 [2]
    Units: percentage of participants
        number (not applicable)
    Notes
    [2] - The study was stopped due to low enrollment; analyses of efficacy end points were not performed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With On-treatment Virologic Failure

    Close Top of page
    End point title
    Percentage of Participants With On-treatment Virologic Failure
    End point description
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ throughout treatment with at least 6 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 24-week treatment)
    End point values
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Number of subjects analysed
    0 [3]
    Units: percentage of participants
        number (not applicable)
    Notes
    [3] - The study was stopped due to low enrollment; analyses of efficacy end points were not performed
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Post-treatment Relapse

    Close Top of page
    End point title
    Percentage of Participants With Post-treatment Relapse
    End point description
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
    End point type
    Secondary
    End point timeframe
    From the end of treatment through 12 weeks after the last dose of study drug
    End point values
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Number of subjects analysed
    0 [4]
    Units: percentage of participants
        number (not applicable)
    Notes
    [4] - The study was stopped due to low enrollment; analyses of efficacy end points were not performed
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Long Term Clinical Outcomes

    Close Top of page
    End point title
    Percentage of Participants With Long Term Clinical Outcomes
    End point description
    The percentage of participants with long term clinical outcomes (de novo hepatocellular carcinoma (HCC) lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above) from first dose of study drug through 24 weeks post-treatment follow-up.
    End point type
    Secondary
    End point timeframe
    up to 48 weeks
    End point values
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Number of subjects analysed
    0 [5]
    Units: percentage of participants
        number (not applicable)
    Notes
    [5] - The study was stopped due to low enrollment; analyses of efficacy end points were not performed
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Recurrent HCV Infection Post Liver Transplant

    Close Top of page
    End point title
    Percentage of Participants With Recurrent HCV Infection Post Liver Transplant
    End point description
    The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.
    End point type
    Secondary
    End point timeframe
    from liver transplant to 24 weeks post-treatment (up to 48 weeks)
    End point values
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Number of subjects analysed
    0 [6]
    Units: percentage of participants
        number (not applicable)
    Notes
    [6] - The study was stopped due to low enrollment; analyses of efficacy end points were not performed
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks for 12-week treatment and up to 28 weeks for 24-week treatment)
    Adverse event reporting additional description
    TEAEs and TESAEs are defined as any adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Reporting group description
    OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without dasabuvir (250 mg twice daily) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.

    Serious adverse events
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Lymphopenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Portal hypertensive gastropathy
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Irritability
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Sep 2015
    The main purpose of this amendment was to add hepatitis C virus (HCV) RNA assessments at Weeks 8 and 16; update inclusion criteria (to allow enrollment of subject who have previously been exposed to sofosbuvir [SOF] but no other HCV direct-acting antiviral agents [DAAs]l clarify definition of compensated cirrhosis); update study rationale and justification; clarify study procedures; and permit subjects with HCV subgenotype 1b (HCV GT1b) to be treated with a ribavirin-free regimen.
    24 Feb 2016
    The purpose of this amendment was to reduce enrollment from 60 subjects to 3 subjects and to reduce the duration of study from 168 weeks to 24 weeks post-treatment due to study closure for low enrolment.

    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA