Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.

Detailed Description
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Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)

Official Title
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Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Viramidine
* Drug: Ribavirin
* Drug: pegylated interferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-naive patients with compensated chronic hepatitis C. HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL). Exclusion Criteria: Severe neuropsychiatric disorders History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease Pregnant or breast-feeding patients

Ages Eligible for Study
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Minimum Age: 18 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: Viramidine|nan|
|Drug: Ribavirin|nan|
|Drug: pegylated interferon alfa-2a|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period. |  |  | 
| - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Efficacy: Undetectable plasma HCV RNA at treatment week 24 |  |  | 
| - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24 |  |  | 
| - Safety: Monitoring of adverse events |  |  | 
| - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2a