search
Back to results

A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ABT-450/r/ABT-267, ABT-333
Ribavirin
Placebo for ABT-450/r/ABT-267
Placebo for ABT-333
Placebo for ribavirin
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Hepatitis C, Treatment-Experienced, Null responder, Partial Responder, Chronic Hepatitis, Hepatitis C Genotype 1, Interferon-Free, Hepatitis C Virus, Relapser, Non responder, Viekira Pak, ombitasvir, ribavirin, ritonavir, paritaprevir, dasabuvir

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
  • Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.
  • Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
  • No evidence of liver cirrhosis.

Exclusion Criteria:

  • Positive screen for drugs or alcohol.
  • Significant sensitivity to any drug.
  • Use of contraindicated medications within 2 weeks of dosing.
  • Certain predefined abnormal laboratory tests.
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ABT-450/r/ABT-267 and ABT-333, plus RBV

    Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV

    Arm Description

    Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

    Secondary Outcome Measures

    Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
    Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
    Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
    Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
    Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
    Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ 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
    October 25, 2012
    Last Updated
    July 29, 2021
    Sponsor
    AbbVie (prior sponsor, Abbott)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01715415
    Brief Title
    A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
    Official Title
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie (prior sponsor, Abbott)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C Infection
    Keywords
    Hepatitis C, Treatment-Experienced, Null responder, Partial Responder, Chronic Hepatitis, Hepatitis C Genotype 1, Interferon-Free, Hepatitis C Virus, Relapser, Non responder, Viekira Pak, ombitasvir, ribavirin, ritonavir, paritaprevir, dasabuvir

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    395 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ABT-450/r/ABT-267 and ABT-333, plus RBV
    Arm Type
    Experimental
    Arm Description
    Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Arm Title
    Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
    Arm Type
    Experimental
    Arm Description
    Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    ABT-450/r/ABT-267, ABT-333
    Other Intervention Name(s)
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Viekira PAK
    Intervention Description
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Intervention Description
    Capsule (double-blind treatment period), tablet (open-label treatment period)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for ABT-450/r/ABT-267
    Intervention Description
    Tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for ABT-333
    Intervention Description
    Tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for ribavirin
    Intervention Description
    Capsule
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
    Description
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame
    12 weeks after the last actual dose of active study drug
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
    Description
    Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
    Time Frame
    At 12 weeks
    Title
    Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
    Description
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame
    12 weeks after the last actual dose of active study drug
    Title
    Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
    Description
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame
    12 weeks after the last actual dose of active study drug
    Title
    Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
    Description
    Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
    Time Frame
    12 weeks after the last actual dose of active study drug
    Title
    Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
    Description
    Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ 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
    Within 12 weeks post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control. Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening. Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV). No evidence of liver cirrhosis. Exclusion Criteria: Positive screen for drugs or alcohol. Significant sensitivity to any drug. Use of contraindicated medications within 2 weeks of dosing. Certain predefined abnormal laboratory tests. Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeff Enejosa, MD
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24720679
    Citation
    Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1604-14. doi: 10.1056/NEJMoa1401561. Epub 2014 Apr 10.
    Results Reference
    result
    PubMed Identifier
    29377566
    Citation
    Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.
    Results Reference
    derived
    Links:
    URL
    http://rxabbvie.com
    Description
    Related Info

    Learn more about this trial

    A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

    We'll reach out to this number within 24 hrs