A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

• 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 and <70 years of age at initiation of treatment

• Body weight between 50 kg and 125 kg at baseline

• Chronic hepatitis C, genotype 1

• Chronic liver disease consistent with HCV infection

• Compensated liver disease (Child-Pugh Grade A)

Exclusion Criteria:

• Pregnant or lactating women, and male partners of pregnant women

• Chronic hepatitis C, genotype 2, 3, 4, 5 or 6

• Previous treatment with interferon or ribavirin

• Positive for hepatitis A, hepatitis B or HIV infection

• History or evidence of a medical condition associated with liver disease other than chronic hepatitis C

• Decompensated liver disease and/or liver disease Child-Pugh classification >6

• Hepatocellular carcinoma

• History or evidence of esophageal bleeding

• Hemoglobinopathy, or any other cause for possible hemolysis

• Hb <11 g/dL in women, <12 g/L in males