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

Completed · Phase 3

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT00093093

Run by

Bausch Health Americas, Inc.

People needed

900

Starts

2004-06-01

Expected to finish

2006-05-01

Last updated by the study team

2012-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• UCSF Fresno- Internal Medicine — Fresno, California, United States
• Keck School of Medicine, University of Southern California — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Orange Coast Medical Group — Newport Beach, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Research and Education, Inc. — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• San Mateo Medical Center — San Mateo, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Rocky Mountain Gastroenterology — Lakewood, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Bach and Godofsky — Bradenton, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Atlanta Academic Research Group — Atlanta, Georgia, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Louisiana State University Memorial Hospital — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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