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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: | 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.
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
Hide Study Locations| United States, California | |
| Los Angeles, California, United States, 90095 | |
| San Francisco, California, United States, 94115 | |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32216 | |
| Miami, Florida, United States, 33136 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| New York, New York, United States, 10032 | |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Fairfax, Virginia, United States, 22031 | |
| United States, Washington | |
| Seattle, Washington, United States, 98104 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N4N1 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z1H2 | |
| Vancouver, British Columbia, Canada, V5Z3P1 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| France | |
| Clichy, France, 92210 | |
| Lyon, France, 69288 | |
| Marseille, France, F13385 | |
| Villejuif, France, 94800 | |
| Germany | |
| Berlin, Germany, 13353 | |
| Hamburg, Germany, 20251 | |
| Hannover, Germany, 30623 | |
| Heidelberg, Germany, 69120 | |
| Mainz, Germany, 55131 | |
| Frankfurt, Germany, 60590 | |
| Greece | |
| Thessaloniki, Greece, 570 10 | |
| Thessaloniki, Greece, 546 42 | |
| Athens, Greece, 115 27 | |
| Ireland | |
| Dublin, Ireland | |
| Italy | |
| Padova, Italy, 35123 | |
| Padova, Italy, 35128 | |
| Torino, Italy, 10134 | |
| Udine, Italy, 33100 | |
| Poland | |
| Bialystok, Poland, 15-540 | |
| Bydgoszcz, Poland, 85-030 | |
| Warsaw, Poland, 01-201 | |
| Singapore | |
| Singapore, Singapore, 119074 | |
| Singapore, Singapore, 169608 | |
| Singapore, Singapore, 529889 | |
| Singapore, Singapore, 308433 | |
| Spain | |
| Barcelona, Spain, 08035 | |
| Barcelona, Spain, 08907 | |
| Barcelona, Spain, 08036 | |
| Madrid, Spain, 28007 | |
| Valencia, Spain, 46009 | |
| Taiwan | |
| Tainan, Taiwan, 704 | |
| Taoyuan Hsien, Taiwan, 333 | |
| Taipei City, Taiwan, 114 | |
| Kaoshiung Hsien, Taiwan, 833 | |
| Taipei, Taiwan | |
| Turkey | |
| Ankara, Turkey | |
| Izmir, Turkey | |
| Besevler -Ankara, Turkey, 06510 | |
| Bursa, Turkey, 16059 | |
| Istanbul, Turkey | |
| Study Chair: | Elsa Mondou, M.D. | Gilead Sciences |
More Information
| Responsible Party: | University of Miami ( Eugene Schiff ) |
| Study ID Numbers: | GS-US-174-0108 |
| Study First Received: | February 28, 2006 |
| Last Updated: | August 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00298363 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatitis; Hepatitis B virus; Tenofovir |
|
Anti-Infective Agents Liver Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Hepatitis, Viral, Human Enzyme Inhibitors Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions Reverse Transcriptase Inhibitors Hepatitis |
Virus Diseases Entecavir Digestive System Diseases Anti-Retroviral Agents Emtricitabine Therapeutic Uses Hepatitis B, Chronic Hepatitis B Tenofovir DNA Virus Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |