An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR
Overview
- Phase
- Phase 4
- Intervention
- COPEGUS
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 59
- Locations
- 20
- Primary Endpoint
- End of Treatment Response Rate at Week 72 in Genotype 1
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients \>/= 18 years of age
- •Chronic hepatitis C, genotype 1, 2, 3
- •Compensated liver disease
- •Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
Exclusion Criteria
- •Decompensated liver disease
- •Signs or symptoms of hepatocellular carcinoma
- •Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Arms & Interventions
Single arm
Intervention: COPEGUS
Single arm
Intervention: peginterferon alfa-2a [Pegasys]
Outcomes
Primary Outcomes
End of Treatment Response Rate at Week 72 in Genotype 1
Time Frame: Week 72
End of treatment response rate at Week 72 was reported for genotype 1.
End of Treatment Response in Genotype 2 and 3
Time Frame: Week 48
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Time Frame: Week 96
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
SVR Rates in Genotype 2 and 3.
Time Frame: Week 72
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Secondary Outcomes
- Percentage of Participants With Adverse Event (AE)(Week 96)