Hepatitis C, Chronic
Conditions
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.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
180 mcg sc weekly
DRUGplacebo
Orally b.i.d.
1000 mg or 1200 mg orally daily
DRUGsetrobuvir
Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24 | 24 weeks |
| Proportion of treatment-naïve patients eligible to stop all treatment at Week 28 | 28 weeks |
| Safety: Incidence of adverse events | up to approximately 72 weeks |
Outcome results
None listed