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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC

Conditions
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Liver Cirrhosis, Chronic Hepatitis C

Intervention / Treatment
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* Drug: peginterferon alfa-2a 180μg
* Drug: peginterferon alfa-2a 90μg
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: peginterferon alfa-2a 180μg<br>* 180μg（s.c.）/week for 48 weeks<br>Drug: ribavirin<br>* 600, 800, or 1,000 mg X 2(p.o.)/day<br>|
| Experimental: 2<br> | Drug: peginterferon alfa-2a 90μg<br>* 90μg(s.c.)/week for 48 weeks<br>Drug: ribavirin<br>* 600, 800, or 1,000 mg X 2(p.o.)/day<br>|
| No Intervention: 3<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL]) |  | week 24 from the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical response (normalization of serum alanine aminotransferase activity) |  | at the end of treatment and week 24 form the end of treatment | 
| Virological response (HCV-RNA < 50 IU per milliliter) |  | at the end of treatment and week 24 form the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHC with compensated LC