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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00298363 |
The study is designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (DF), emtricitabine/tenofovir DF, and entecavir in the treatment of hepatitis B patients with decompensated liver disease.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: tenofovir disoproxil fumarate Drug: emtricitabine / tenofovir disoproxil fumarate Drug: entecavir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2, Double-Blind, Multi-Center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine/Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects With Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantation. |
Estimated Enrollment: | 100 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
tenofovir disoproxil fumarate 300 mg tablet, once-daily |
Drug: tenofovir disoproxil fumarate
300 mg tablet, once-daily
|
2: Experimental
emtricitabine / tenofovir disoproxil fumarate 200 mg tablet / 300 mg tablet, once daily (combination pill) |
Drug: emtricitabine / tenofovir disoproxil fumarate
200 mg tablet / 300 mg tablet, once daily (combination pill)
|
3: Experimental
entecavir 0.5 or 1 mg tablet, once daily |
Drug: entecavir
0.5 or 1 mg tablet, once daily
|
Safety will be assessed by evaluating adverse events, laboratory abnormalities and the development of drug-resistant mutations. Efficacy will be evaluated for reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in HBV DNA, changes in liver enzymes, and the generation of antibody to virus.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for participation in the study.
Decompensated liver disease with all of the following:
Exclusion Criteria:
A patient who meets any of the following exclusion criteria cannot be enrolled in the study:
Study Chair: | Elsa Mondou, M.D. | Gilead Sciences |
Responsible Party: | University of Miami ( Eugene Schiff ) |
Study ID Numbers: | GS-US-174-0108 |
Study First Received: | February 28, 2006 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00298363 |
Health Authority: | United States: Food and Drug Administration |
Hepatitis; Hepatitis B virus; Tenofovir |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Recurrence Hepatitis Virus Diseases Entecavir |
Digestive System Diseases Emtricitabine Hepatitis B, Chronic Hepatitis B Tenofovir 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 |