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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00507507 |
Purpose
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 |
| Enrollment: | 126 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Tenofovir DF 300 mg + Emtricitabine 200 mg
|
Drug: tenofovir disoproxil plus emtricitabine
tenofovir disoproxil 300 mg oral tablet once daily plus emtricitabine 200 mg oral capsule once daily
|
|
B: Experimental
Tenofovir DF
|
Drug: tenofovir disoproxil fumarate
tenofovir disoproxil 300 mg oral tablet once daily plus matching emtricitabine placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| San Francisco, California, United States, 11355 | |
| San Diego, California, United States, 92115 | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Miami, Florida, United States, 33136 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| New York, New York, United States, 10029-6574 | |
| Manhasset, New York, United States, 11030 | |
| New York, New York, United States, 10021 | |
| United States, Tennessee | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Washington | |
| Seattle, Washington, United States, 98111 | |
| Australia, New South Wales | |
| Westmead, New South Wales, Australia, 2145 | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Victoria | |
| Melbourne, Victoria, Australia, 3004 | |
| Heidelburg, Victoria, Australia, 3081 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N4N1 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z1H2 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| France | |
| Strasbourg, France, 67091 | |
| Lille, France, 59037 | |
| Lyon, France, 69288 | |
| Germany | |
| Duesseldorf, Germany, 40237 | |
| Hamburg, Germany, 20251 | |
| Hannover, Germany, 30623 | |
| Berlin, Germany, 10969 | |
| Berlin, Germany, 13353 | |
| Frankfurt, Germany, 60590 | |
| Herne, Germany, 44623 | |
| Heidelberg, Germany, 69120 | |
| Mainz, Germany, 55131 | |
| Hong Kong | |
| Shatin, Hong Kong | |
| Tai Po, Hong Kong | |
| Pokfulam, Hong Kong | |
| New Zealand | |
| Hamilton, New Zealand | |
| New Zealand, Auckland | |
| Grafton, Auckland, New Zealand, 1150 | |
| Poland | |
| Bydgoszcz, Poland, 85-030 | |
| Chorzow, Poland, 41-500 | |
| Warszawa, Poland, 01-201 | |
| Singapore | |
| Singapore, Singapore, 529889 | |
| Singapore, Singapore, 119074 | |
| Taiwan | |
| Kaoshiung, Taiwan, 833 | |
| Taipei, Taiwan | |
| Kaohsiung, Taiwan, 807 | |
| Tainan, Taiwan, 107 | |
| United Kingdom | |
| London, United Kingdom, NW3 2QG | |
| Sheffield, United Kingdom, S10 2JF | |
More Information
| 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: | February 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00507507 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
tenofovir monotherapy emtricitabine combination hepatitis B |
|
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 Digestive System Diseases Anti-Retroviral Agents Emtricitabine Therapeutic Uses Hepatitis B, Chronic Hepatitis B Tenofovir DNA Virus Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |