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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00298363 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
tenofovir disoproxil fumarate 300 mg tablet, once-daily |
Drug: tenofovir disoproxil fumarate
300 mg tablet, once-daily
|
|
Experimental: 2
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)
|
|
Experimental: 3
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.
Eligibility| 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:
Contacts and Locations
Show 55 Study Locations| Study Director: | Stephen J Rossi, PharmD | Gilead Sciences |
More Information
| Responsible Party: | Eugene Schiff, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00298363 History of Changes |
| Other Study ID Numbers: | GS-US-174-0108 |
| Study First Received: | February 28, 2006 |
| Last Updated: | December 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatitis; Hepatitis B virus; Tenofovir |
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Liver Diseases Hepatitis B, Chronic Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
Tenofovir disoproxil Tenofovir Entecavir Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |