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Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

Primary Purpose

HCV, Hepatitis C Infection, Genotype 4

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
2 DAA
RBV
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV focused on measuring Genotype 4, non-responder, treatment experienced, HCV, naive, relapser, hepatitis infection, compensated cirrhosis, hepatitis c, Cirrhosis, Egypt, null responder, partial responder

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)

  • Subjects must meet one of the following:

    • Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
    • Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV);
  • Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
  • In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
  • In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
  • HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
  • abnormal laboratory tests
  • self-reports current drinking more than 2 drinks per day
  • current enrollment in another investigational study
  • previous treatment with a direct acting antiviral agent (DAA) containing regimen
  • In substudy 1, evidence of liver cirrhosis
  • In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Arm A

    Arm B

    Arm C

    Arm Description

    ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.

    ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

    ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
    SVR12 was defined as 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.
    Number of Participants With Adverse Events
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

    Secondary Outcome Measures

    Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm
    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.
    Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm
    Post-treatment relapse was defined as 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 < LLOQ at the end of treatment.

    Full Information

    First Posted
    September 19, 2014
    Last Updated
    July 28, 2021
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02247401
    Brief Title
    Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
    Official Title
    An Open-Label Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 4, 2014 (undefined)
    Primary Completion Date
    August 1, 2016 (Actual)
    Study Completion Date
    August 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
    Detailed Description
    Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HCV, Hepatitis C Infection, Genotype 4
    Keywords
    Genotype 4, non-responder, treatment experienced, HCV, naive, relapser, hepatitis infection, compensated cirrhosis, hepatitis c, Cirrhosis, Egypt, null responder, partial responder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Active Comparator
    Arm Description
    ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
    Arm Title
    Arm B
    Arm Type
    Active Comparator
    Arm Description
    ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
    Arm Title
    Arm C
    Arm Type
    Active Comparator
    Arm Description
    ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
    Intervention Type
    Drug
    Intervention Name(s)
    2 DAA
    Intervention Description
    ABT-450/r/ABT-267 tablets
    Intervention Type
    Drug
    Intervention Name(s)
    RBV
    Intervention Description
    Ribavirin tablets
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
    Description
    SVR12 was defined as 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.
    Time Frame
    12 weeks after last dose
    Title
    Number of Participants With Adverse Events
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
    Time Frame
    Screening until 30 days after last dose
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm
    Description
    On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.
    Time Frame
    Up to 12 or 24 weeks after first dose
    Title
    Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm
    Description
    Post-treatment relapse was defined as 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 < LLOQ at the end of treatment.
    Time Frame
    Up to 12 weeks after first dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening) Subjects must meet one of the following: Treatment-naive: Subject has never received antiviral treatment for HCV infection OR Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV); Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma Exclusion Criteria: Females who are pregnant or breastfeeding Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype abnormal laboratory tests self-reports current drinking more than 2 drinks per day current enrollment in another investigational study previous treatment with a direct acting antiviral agent (DAA) containing regimen In substudy 1, evidence of liver cirrhosis In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarah Kopecky-Bromberg, PhD
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28404110
    Citation
    Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, Soliman R, Mohey MA, Allam N, Zayed N, Asselah T, Hall C, Redman R, Mobashery N, Doss W. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):36-44. doi: 10.1016/S2468-1253(16)30002-4. Epub 2016 Jun 16. Erratum In: Lancet Gastroenterol Hepatol. 2016 Sep;1(1):e1.
    Results Reference
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    Learn more about this trial

    Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

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