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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00307489 |
This study will explore the efficacy, safety and tolerability of tenofovir DF 300 mg monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable HBV DNA).
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: tenofovir DF Drug: emtricitabine /tenofovir DF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated With Adefovir Dipivoxil for Chronic Hepatitis B and Having Persistent Viral Replication |
Enrollment: | 106 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Active chronic HBV infection with all the following:
Exclusion Criteria:
United States, New York | |
Flushing, New York, United States, 11355 | |
United States, Virginia | |
Fairfax, Virginia, United States, 22031 | |
Norfolk, Virginia, United States, 23502 | |
France | |
Angers, France, 49933 | |
Marseille, France, 13285 | |
Paris, France, 75013 | |
Strasbourg, France, 67090 | |
Clichy, France, 92110 | |
Lille, France, 59037 | |
Rouen, France, 76031 | |
Lyon, France, 69288 | |
Germany | |
Berlin, Germany, 13353 | |
Herne, Germany, 44623 | |
Erlangen, Germany, 91054 | |
Munchen, Germany, 81377 | |
Berlin, Germany, 10969 | |
Frankfurt, Germany, 60590 | |
Bonn, Germany, 53105 | |
Hamburg, Germany, 20246 | |
Spain | |
Sevilla, Spain, 41014 | |
Granada, Spain, 18014 | |
Malaga, Spain, 29010 | |
Granada, Spain, 18012 | |
Barcelona, Spain, 08003 | |
Sevilla, Spain, 41013 |
Study Chair: | David Oldach, MD | Gilead Sciences |
Responsible Party: | Charite Campus Virchow-Klinikum ( Thomas Berg ) |
Study ID Numbers: | GS-US-174-0106 |
Study First Received: | March 24, 2006 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00307489 |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis Virus Diseases Digestive System Diseases Emtricitabine Hepatitis B, Chronic |
Hepatitis B Tenofovir DNA Virus Infections Adefovir dipivoxil Viremia Adefovir Tenofovir disoproxil |
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 |