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

Bausch Health Americas, Inc.900 enrolled

Overview

This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

900

Conditions

Chronic Hepatitis C

Interventions

ViramidineDRUG

RibavirinDRUG

pegylated interferon alfa-2bDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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, opthalmologic disorders including severe retinopathy, or immune mediated disease * Pregnant or breast-feeding patients

Outcomes

Primary Outcomes

- 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 Outcomes

- 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

Data from ClinicalTrials.gov

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