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

Study Overview
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Brief Summary
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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.

Detailed Description
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Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo. All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

Official Title
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A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: peginterferon alfa-2a
* Drug: rivavirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: peginterferon alfa-2a|nan|
|Drug: rivavirin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical response (normalization of serum alanine aminotransferase activity), |  |  | 
| Virological response (HCV-RNA <50IU per milliliter) at the end of therapy. |  |  |