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

Study Timeline

• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Study Start: 2014-11-24
• Primary Completion: 2017-07-14
• Study Completion: 2017-07-14
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01

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