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| Sponsor: | Achillion Pharmaceuticals |
|---|---|
| Information provided by: | Achillion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034359 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | ACH443-003 |
| Study First Received: | April 26, 2002 |
| Last Updated: | July 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00034359 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
E-antigen positive Treatment Naive Chronic Hepatitis B, Achillion |
|
Anti-Infective Agents Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions |
Hepatitis Virus Diseases Digestive System Diseases Hepatitis B, Chronic Therapeutic Uses Hepatitis B DNA Virus Infections |