A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.

Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))

• elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening

• liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

• Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)

• leukopenia (fewer than 3,000 white blood cells per cubic millimeter)

• thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)

• anemia (less than 12 g hemoglobin per deciliter )

• hepatitis B co-infection

• decompensated liver disease

• organ transplant

• creatinine clearance less than 50 milliliters per minute

• poorly controlled psychiatric disease

• poorly controlled diabetes

• malignant neoplastic disease

• severe cardiac or chronic pulmonary disease

• immunologically mediated disease

• retinopathy.