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Sponsored by: |
Valeant Pharmaceuticals North America |
---|---|
Information provided by: | Valeant Pharmaceuticals North America |
ClinicalTrials.gov Identifier: | NCT00093093 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: Viramidine Drug: Ribavirin Drug: pegylated interferon alfa-2a |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C |
Estimated Enrollment: | 900 |
Study Start Date: | June 2004 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
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 patients with chronic hepatitis C (CHC)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | RNA003142-302 |
Study First Received: | September 30, 2004 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00093093 |
Health Authority: | United States: Food and Drug Administration |
Viramidine Ribavirin Valeant Hepatitis C Pegylated interferon alfa-2a |
Interferon-alpha Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human Hepatitis |
Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |