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

June 21, 2012 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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)

Study Type

Interventional

Enrollment

900

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- 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
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNA003142-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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