Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C

NCT ID: NCT00305383

Last Updated: 2012-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-05-31

Brief Summary

The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.

Detailed Description

This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Viramidine

Intervention Type: DRUG

Peginterferon alfa-2b

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients
• Body weight greater than 61 kg and not more than 87.3 kg
• HCV RNA greater than 2 million copies/mL
• Elevated measured or historical alanine aminotransferase
• Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males
• Calculated creatinine clearance greater than 70 mL/min

Exclusion Criteria

• Cirrhosis of the liver
• Alanine aminotransferase greater than 3 times the upper limit of normal
• Severe neuropsychiatric disorders
• History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
• Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph T. Doyle

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

University of Southern California -- Keck School of Medicine

Los Angeles, California, United States

San Mateo Medical Center

San Mateo, California, United States

Bach and Godofsky

Bradenton, Florida, United States

University of Miami -- Center for Liver Diseases

Miami, Florida, United States

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

Maryland Digestive Disease Research

Laurel, Maryland, United States

Atlantic Gastroenterology Associates

Egg Harbor, New Jersey, United States

Liver Center of Long Island

Plainview, New York, United States

Thomas Jefferson University -- Gastroenterology and Hepatology

Philadelphia, Pennsylvania, United States

Mountain West Gastroenterology -- Research Office

Salt Lake City, Utah, United States

Metropolitan Research -- Georgetown Medical Center

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

RNA003142-202

Identifier Type: -

Identifier Source: org_study_id