SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]
- Registration Number
- NCT00412334
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- adult patients >=18 years of age, with CHC genotype 1;
- patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for >=12 weeks;
- patients who have discontinued PEGASYS/ribavirin >=4 weeks prior to enrollment;
- compensated liver disease.
- other forms of liver disease;
- infection with HIV, HAV, HBV;
- hepatocellular cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 peginterferon alfa-2a [Pegasys] - 2 peginterferon alfa-2a [Pegasys] - 1 Copegus - 3 Copegus - 2 Copegus - 3 peginterferon alfa-2a [Pegasys] - 4 Copegus - 4 peginterferon alfa-2a [Pegasys] -
- Primary Outcome Measures
Name Time Method Sustained viral response Week 72
- Secondary Outcome Measures
Name Time Method Percentage of patients with >=2log drop of HCV-RNA Week 4, 12, 24. Percentage of patients with non-detectable HCV-RNA Week 48 Relapse rate Throughout study.