Overview

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