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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00507507 |
The main objective of the study is to evaluate the antiviral activity of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy for the treatment of chronic Hepatitis B
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: tenofovir disoproxil fumarate Drug: tenofovir disoproxil plus emtricitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B |
Estimated Enrollment: | 100 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Tenofovir DF 300 mg + Emtricitabine 200 mg
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Drug: tenofovir disoproxil plus emtricitabine
tenofovir disoproxil 300 mg oral tablet once daily plus emtricitabine 200 mg oral capsule once daily
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B: Experimental
Tenofovir DF
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Drug: tenofovir disoproxil fumarate
tenofovir disoproxil 300 mg oral tablet once daily plus matching emtricitabine placebo
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The efficacy of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy will be evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes) and the development of any drug resistant mutations. The safety and tolerability of both tenofovir and tenofovir plus emtricitabine will also be evaluated by routine monitoring for adverse events and changes in laboratory parameters.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Gilead Sciences ( David Oldach, MD/Director Clinical Research ) |
Study ID Numbers: | GS-US-203-0101 |
Study First Received: | July 25, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00507507 |
Health Authority: | United States: Food and Drug Administration |
tenofovir monotherapy emtricitabine combination hepatitis B |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Emtricitabine Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Tenofovir Hepatitis, Viral, Human DNA Virus Infections Tenofovir disoproxil |
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Reverse Transcriptase Inhibitors |