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A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
placebo
ribavirin [Copegus]
setrobuvir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age inclusive
  • Documented chronic hepatitis C
  • Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
  • Serum HCV RNA >/= 50,000 IU/mL at screening
  • HCV antibody positive at screening
  • HCV genotype 1
  • Body mass index (BMI) 18-38 kg/m2
  • In good health other than chronic HCV infection in the judgment of the principal investigators
  • Negative for hepatitis B and HIV infection

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • For treatment-naïve patients: any previous treatment for HCV infection
  • For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
  • Co-infection with HIV or hepatitis C virus (HBV)
  • History or evidence of decompensated liver disease
  • History or evidence of hepatocellular carcinoma
  • History of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study
  • Poorly controlled diabetes mellitus
  • One or more additional known primary causes of liver disease other than hepatitis C
  • History of acute or chronic pancreatitis
  • Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Active Comparator

    Setrobuvir

    Arm Description

    Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)

    Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)

    Outcomes

    Primary Outcome Measures

    Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs

    Secondary Outcome Measures

    Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24
    Proportion of treatment-naïve patients eligible to stop all treatment at Week 28
    Safety: Incidence of adverse events

    Full Information

    First Posted
    July 17, 2013
    Last Updated
    November 1, 2016
    Sponsor
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01903954
    Brief Title
    A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
    Official Title
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hoffmann-La Roche

    4. Oversight

    5. Study Description

    Brief Summary
    This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending on response. Treatment-experienced patients categorized as relapsers, partial responders and viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus for 48 weeks. Treatment-experienced patients categorized as null-responders to previous pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus Pegasys and Copegus for 48 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    283 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Comparator
    Arm Type
    Active Comparator
    Arm Description
    Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
    Arm Title
    Setrobuvir
    Arm Type
    Experimental
    Arm Description
    Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
    Intervention Type
    Drug
    Intervention Name(s)
    peginterferon alfa-2a [Pegasys]
    Intervention Description
    180 mcg sc weekly
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Orally b.i.d.
    Intervention Type
    Drug
    Intervention Name(s)
    ribavirin [Copegus]
    Intervention Description
    1000 mg or 1200 mg orally daily
    Intervention Type
    Drug
    Intervention Name(s)
    setrobuvir
    Other Intervention Name(s)
    ANA598
    Intervention Description
    Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks
    Primary Outcome Measure Information:
    Title
    Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs
    Time Frame
    24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)
    Secondary Outcome Measure Information:
    Title
    Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24
    Time Frame
    24 weeks
    Title
    Proportion of treatment-naïve patients eligible to stop all treatment at Week 28
    Time Frame
    28 weeks
    Title
    Safety: Incidence of adverse events
    Time Frame
    up to approximately 72 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients, 18 to 65 years of age inclusive Documented chronic hepatitis C Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment Serum HCV RNA >/= 50,000 IU/mL at screening HCV antibody positive at screening HCV genotype 1 Body mass index (BMI) 18-38 kg/m2 In good health other than chronic HCV infection in the judgment of the principal investigators Negative for hepatitis B and HIV infection Exclusion Criteria: Pregnant or breastfeeding women For treatment-naïve patients: any previous treatment for HCV infection For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection Co-infection with HIV or hepatitis C virus (HBV) History or evidence of decompensated liver disease History or evidence of hepatocellular carcinoma History of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study Poorly controlled diabetes mellitus One or more additional known primary causes of liver disease other than hepatitis C History of acute or chronic pancreatitis Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trials
    Organizational Affiliation
    Hoffmann-La Roche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C

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