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Sponsored by: |
Triangle Pharmaceuticals |
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Information provided by: | Triangle Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00044135 |
The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Drug: clevudine (drug) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Partially-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of 12 Weeks of Treatment with Clevudine (10 mg, 30 mg or 50 mg QD) in Patients Infected with Hepatitis B Virus. |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital, Jefferson Medical College | |
Philadelphia, Pennsylvania, United States, 19107 | |
Canada | |
Viridae | |
Vancouver, Canada, V6Z1Y8 | |
University of British Columbia, Downtown Infectious Disease Clinic | |
Vancouver, Canada, V6Z2C7 | |
China | |
The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital | |
Hong Kong, China | |
Prince of Wales Hospital, Department of Medicine and Therapeutics | |
Hong Kong, China | |
France | |
Hospital St Louis, Service de Medecine Interne | |
Paris, France, 75010 | |
Hospital Beaujon, Service Hepatologie Centre Pierre Abrami | |
Clichy, France, 92118 | |
Hospital Dieu, Service Hepatogastroenterologie-endoscopie | |
Lyon, France, 69288 | |
Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie | |
Vandoeuvre, France, 54511 |
Study ID Numbers: | L-FMAU-102 B |
Study First Received: | August 20, 2002 |
ClinicalTrials.gov Identifier: | NCT00044135 History of Changes |
Health Authority: | Unspecified |
clevudine hepatitis B |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases 2'-fluoro-5-methylarabinosyluracil |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Antiviral Agents |
Anti-Infective Agents Liver Diseases Hepatitis, Viral, Human Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions Hepatitis |
Virus Diseases Digestive System Diseases Therapeutic Uses 2'-fluoro-5-methylarabinosyluracil Hepatitis B DNA Virus Infections |