Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Gilead Sciences |
---|---|
Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00507689 |
The objective of this study is to evaluate the safety and antiviral efficacy of the combination therapy (emtricitabine/tenofovir disoproxil fumarate), plus or minus Hepatitis B Immunoglobulin (HBIG) in preventing the recurrence of chronic hepatitis B after a patient (who was chronically infected with hepatitis B pre-liver transplant) has undergone a liver transplant.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: emtricitabine/tenofovir disoproxil fumarate plus Hepatitis B Immunoglobulin Drug: emtricitabine/tenofovir disoproxil fumarate |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Open-Label Randomized Study to Evaluate the Efficacy and Safety of the Combination Product, Emtricitabine/Tenofovir Disoproxil Fumarate in the Presence or Absence of Hepatitis B Immunoglobulin (HBIG) in Preventing Recurrence of Chronic Hepatitis B (CHB) Post-Orthotopic Liver Transplant (OLT) |
Estimated Enrollment: | 50 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
emtricitabine/tenofovir disoproxil fumarate plus Hepatitis B Immunoglobulin
|
Drug: emtricitabine/tenofovir disoproxil fumarate plus Hepatitis B Immunoglobulin
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg fixed dose combination tablet given orally once daily Hepatitis B Immunoglobulin will be given (either IV or IM) at a dose and frequency per the investigative site protocol |
B: Experimental
emtricitabine/tenofovir disoproxil fumarate
|
Drug: emtricitabine/tenofovir disoproxil fumarate
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg fixed dose combination tablet given orally once daily
|
After a minimum of 9 months of HBIG treatment plus oral anti-HBV therapy (3 months prior to study entry and 6 months on study) patients are randomized to discontinue HBIG and continue emtricitabine/tenofovir DF only or to continue on HBIG plus emtricitabine/tenofovir DF. The antiviral efficacy of treatment will be assessed by measuring virus levels in the blood (HBV DNA). Safety and tolerability will be monitored by assessing adverse events and various laboratory parameters.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jane Anderson, PhD | jane.anderson@gilead.com |
United States, California | |
Recruiting | |
Los Angeles, California, United States, 90048 | |
Recruiting | |
San Francisco, California, United States, 94143 | |
Recruiting | |
San Francisco, California, United States, 94115 | |
United States, Georgia | |
Recruiting | |
Atlanta, Georgia, United States, 30322 | |
United States, New York | |
Recruiting | |
New York, New York, United States, 10029 | |
Recruiting | |
New York, New York, United States, 10016 |
Principal Investigator: | Lewis Teperman, MD | New York University Medical Center |
Responsible Party: | Gilead Sciences ( David Oldach, MD, Director Clinical Research ) |
Study ID Numbers: | GS-US-203-0107 |
Study First Received: | July 25, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00507689 |
Health Authority: | United States: Food and Drug Administration |
Truvada HBIG Chronic Hepatitis B Recurrence Post Orthotopic Liver Transplant |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Recurrence Hepatitis Virus Diseases Antibodies Digestive System Diseases |
Emtricitabine Hepatitis B, Chronic Hepatitis B Tenofovir DNA Virus Infections Immunoglobulins Tenofovir disoproxil |
Anti-Infective Agents Disease Attributes Anti-HIV Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors Hepadnaviridae Infections |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Pathologic Processes Anti-Retroviral Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |