An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C
Completed
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01679834
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7500
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Diagnosis of chronic hepatitis C
- Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label
Exclusion Criteria
- Contraindications against Pegasys or Copegus
- Not willing or unable to sign written informed consent form
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virological response 24 weeks after end of treatment
- Secondary Outcome Measures
Name Time Method Rapid virological response 4 weeks after start of treatment Early Virological Response 12 weeks after start of treatment Safety: incidence of adverse events up to 24 weeks after end of treatment