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An Open Label Study to Evaluate the Safety and Effect on Sustained Virological Response of PEGASYS Plus Ribavirin in Patients With Hemophilia A and Chronic Hepatitis C
This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following 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 individuals.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 14 |
| Start date | 2003-06 |
| Completion | 2006-07 |
Conditions
- Hepatitis C, Chronic
Interventions
- peginterferon alfa-2a [Pegasys]
- ribavirin
Primary outcomes
- SVR — Week 72
Countries
Mexico