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| Sponsor: | Bader, Ted, M.D. |
|---|---|
| Information provided by: | Bader, Ted, M.D. |
| ClinicalTrials.gov Identifier: | NCT00994773 |
Purpose
The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The investigators propose phase 1 studies in 48 chronic hepatitis B human carriers who have never been treated before. Doses of drugs will remain at or below FDA-approved dosage levels for cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will have simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in each arm will be filled consecutively and not concurrently. The definition of efficacy for simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous safety tests and stop rules are noted in the protocol.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: Simvastatin Drug: Tenofovir Drug: Entecavir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B |
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Simvastatin: Experimental
Simvastatin orally
|
Drug: Simvastatin
daily doses for 14 days
|
|
Simvastatin and tenofovir: Experimental
Simvastatin combined with tenofovir
|
Drug: Simvastatin
daily doses for 14 days
Drug: Tenofovir
|
|
Simvastatin and entecavir: Experimental
Simvastatin combined with entecavir
|
Drug: Simvastatin
daily doses for 14 days
Drug: Entecavir
Entecavir
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paula Allen, MA | 405-456-3982 | Paula.Allen@va.gov |
| Contact: Joe Cardello, PA | 405-456-3982 | Joe-Cardello@va.gov |
| United States, Oklahoma | |
| VA Medical Center | |
| Oklahoma City, Oklahoma, United States, 74104 | |
| Principal Investigator: | Teddy Bader, M.D. | University of Oklahoma |
More Information
| Responsible Party: | University of Oklahoma Health Sciences Center/VA Medical Center ( Ted Bader, M.D., Director of Liver Diseases, ) |
| Study ID Numbers: | HBV 106707 |
| Study First Received: | October 10, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00994773 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Hepatitis B simvastatin HBV DNA |
|
Antimetabolites Anti-Infective Agents Liver Diseases Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Hepatitis, Viral, Human Hepadnaviridae Infections Reverse Transcriptase Inhibitors Entecavir Anti-Retroviral Agents Hepatitis B, Chronic Therapeutic Uses Hepatitis B Tenofovir |
Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil Anti-HIV Agents Simvastatin Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases DNA Virus Infections |