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Sponsored by: |
Pharmasset |
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Information provided by: | Pharmasset |
ClinicalTrials.gov Identifier: | NCT00496002 |
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 and 96 weeks.
Condition | Intervention | Phase |
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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 Positive Chronic Hepatitis Due to Hepatitis B Virus |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: clinical.trials@pharmasset.com clinical.trials@pharmasset.com | clinical.trials@pharmasset.com |
Study Director: | M. Michelle Berrey, MD, MPH | Pharmasset |
Study ID Numbers: | CI-PSI-5268-06-305 |
Study First Received: | July 2, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00496002 |
Health Authority: | United States: Food and Drug Administration |
Hepatitis B virus Nucleoside Treatment-Naïve Patients with HBeAg Positive |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic 2'-fluoro-5-methylarabinosyluracil |
Hepatitis B Hepatitis, Viral, Human Adefovir dipivoxil DNA Virus Infections Adefovir |
Anti-Infective Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |