Status:
TERMINATED
Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 re...
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 plac...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00305383
Start Date
November 1 2005
End Date
May 1 2007
Last Update
June 22 2012
Active Locations (11)
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1
University of Southern California -- Keck School of Medicine
Los Angeles, California, United States, 90033
2
San Mateo Medical Center
San Mateo, California, United States, 94403
3
Bach and Godofsky
Bradenton, Florida, United States, 34205
4
University of Miami -- Center for Liver Diseases
Miami, Florida, United States, 33136