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

Bausch Health Americas, Inc.0 sites900 target enrollmentDecember 2003

ConditionsChronic Hepatitis C

DrugsViramidine Ribavirin pegylated interferon alfa-2b

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: Bausch Health Americas, Inc.
Enrollment: 900
Primary Endpoint: - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Detailed Description

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)

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

January 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch Health Americas, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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