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| Sponsor: | Pharmasset |
|---|---|
| Information provided by: | Pharmasset |
| ClinicalTrials.gov Identifier: | NCT00496158 |
Purpose
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis Hepatitis B |
Drug: Clevudine Drug: Adefovir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared With Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients With HBeAg Negative Chronic Hepatitis Due to Hepatitis B Virus |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 120 Study Locations| Study Director: | M Michelle Berrey, MD, MPH | Pharmasset |
More Information
| Study ID Numbers: | CI-PSI-5268-06-306 |
| Study First Received: | July 2, 2007 |
| Last Updated: | April 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00496158 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus hepatitis b virus |
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Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Hepatitis, Viral, Human Enzyme Inhibitors Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Hepatitis |
Virus Diseases Digestive System Diseases Anti-Retroviral Agents Therapeutic Uses 2'-fluoro-5-methylarabinosyluracil Hepatitis B DNA Virus Infections Adefovir dipivoxil Adefovir Nucleic Acid Synthesis Inhibitors |