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Sponsors and Collaborators: |
University of Washington Gilead Sciences GlaxoSmithKline |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00230477 |
This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B.
The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.
Condition | Intervention | Phase |
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Hepatitis B |
Drug: Hepsera Drug: Hepsera and lamivudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Adefovir Dipivoxil Versus Adefovir Dipivoxil Plus Lamivudine for the Treatment of Chronic Hepatitis B in Patients With Normal Baseline ALT |
Enrollment: | 19 |
Study Start Date: | April 2003 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
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Mono therapy: Active Comparator
Hepsera
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Drug: Hepsera |
Combo therapy: Active Comparator | Drug: Hepsera and lamivudine |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
Harborview Medical Center | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | John D Scott, MD, MS | University of Washington |
Study ID Numbers: | 03-5944-A03 |
Study First Received: | September 12, 2005 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00230477 |
Health Authority: | United States: Institutional Review Board |
Hepatitis B |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Hepatitis B, Chronic |
Hepatitis B Lamivudine Hepatitis, Viral, Human Adefovir dipivoxil DNA Virus Infections Adefovir |
Anti-Infective Agents Anti-HIV 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 |