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

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Liver Cirrhosis; Chronic Hepatitis C

Treatments: Drug: peginterferon alfa-2a 180μg; Drug: peginterferon alfa-2a 90μg; Drug: ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00304551

JV19595

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: ribavirin

Drug: peginterferon alfa-2a 180μg

2

Experimental group

Treatment:

Drug: ribavirin

Drug: peginterferon alfa-2a 90μg

3

No Intervention group