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An Open-label, Multicenter, Efficacy and Safety Study of Pegasys® Plus Ribavirin in Patients With Chronic HCV Infection Who Are Unable to Tolerate or Who Do Not Respond to 12 Weeks of Therapy With PEGIntron ® Plus Ribavirin
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 57 |
| Start date | 2003-01 |
| Completion | 2006-03 |
Conditions
- Hepatitis C, Chronic
Interventions
- Ribavirin
- peginterferon alfa-2a [Pegasys]
Primary outcomes
- Number of Pegasys and Ribavirin Therapy Completers — 36 weeks for Non-Tolerators and 60 weeks for Non-Responders
Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.
Countries
United States