A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

• Status: Completed
• Trial end date: 2013-06-10
• Target enrollment: 0
• Participant gender: All

Summary

This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test

• Documented pre-treatment HCV RNA quantitative result

• Compensated liver disease (Child-Pugh Grade A)

• Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)

Exclusion Criteria:

• Decompensated liver disease (Child-Pugh Class B or C cirrhosis)

• Co-infection with active hepatitis A and/or hepatitis B

• History or evidence of a medical condition associated with liver disease other than HCV

• Signs and symptoms of hepatocellular carcinoma

• History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease

• Therapy with antineoplastic treatment
• Diabetes mellitus in subjects receiving an insulin therapy

• Evidence of severe retinopathy

• Pregnant or breast-feeding women, and male partners of women who are pregnant