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Sponsored by: |
Achillion Pharmaceuticals |
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Information provided by: | Achillion Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00034359 |
The purpose of this study is to determine the safety and anti-HBV activity of ACH-126, 443 (beta-L-Fd4C) in comparison to lamivudine or placebo in treatment naive adults with chronic Hepatitis B infection.
Condition | Intervention | Phase |
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Hepatitis B, Chronic |
Drug: ACH-126, 443 (beta-L-Fd4C) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
Clinic of Gastroenterology | |
Sofia, Bulgaria | |
Foundation of Gastroenterology | |
Sofia, Bulgaria | |
Former Yugoslavia | |
Clinic Center of Serbia, Institute of Infectious Disease | |
Belgrade, Former Yugoslavia | |
Clinic of Novi Sad | |
Novi Sad, Former Yugoslavia |
Investigator: | Lisa M Dunkle, M.D. | Achillion Pharmaceuticals |
Study ID Numbers: | ACH443-003 |
Study First Received: | April 26, 2002 |
Last Updated: | July 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00034359 |
Health Authority: | United States: Food and Drug Administration |
E-antigen positive Treatment Naive Chronic Hepatitis B, Achillion |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
Hepadnaviridae Infections |