Status:
COMPLETED
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.
Detailed Description
Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive pa...
Eligibility Criteria
Inclusion
- 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
- 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, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Pregnant or breast-feeding patients
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00093093
Start Date
June 1 2004
End Date
May 1 2006
Last Update
June 22 2012
Active Locations (100)
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1
University of Arizona
Tucson, Arizona, United States, 85724-5136
2
UCSF Fresno- Internal Medicine
Fresno, California, United States, 93702
3
Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90033
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048