A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01903954
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Comparator peginterferon alfa-2a [Pegasys] Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) Active Comparator placebo Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) Setrobuvir peginterferon alfa-2a [Pegasys] 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) Active Comparator ribavirin [Copegus] Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) Setrobuvir ribavirin [Copegus] 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) Setrobuvir setrobuvir 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)
- Primary Outcome Measures
Name Time Method 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 24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events up to approximately 72 weeks Proportion of treatment-naïve patients eligible to stop all treatment at Week 28 28 weeks Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24 24 weeks