A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.

Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

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

Details

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

Criteria

Inclusion Criteria:

• Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.

Exclusion Criteria:

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

• Thrombocytopenia (fewer than 75,000 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