An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Participants with serologically confirmed chronic hepatitis C

• Participants using and accepting a double method of contraception

Exclusion Criteria:

• Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment

• Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin

• Participants previously treated with pegylated interferon and/or ribavirin

• Hepatitis B and Human Immunodeficiency Virus co-infections