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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00161356 |
In this study we are trying to find out the amount of a drug called Ambisome in the liver, the blood, the bile and the fatty tissues of the body. This drug is approved for treatment of infections caused by fungus and is known to be effective against most of the fungal infections, which can happen after liver transplantation. By taking small pieces (less than quarter of a teaspoon) of liver and fat during the liver transplant operation, we can measure how much of the drug is concentrated in the liver. After that, we will measure the level of the drug in the blood and in the bile that comes out of a small tube which is inserted into the bile tube as a routine in all liver transplant patients. These measurements will be taken daily for a week and then weekly for another 3 weeks.
We are inviting you to take part in this study in order to increase our knowledge of the behavior of this drug so that we can find the most effective treatment to prevent fungal infections in liver transplant patients.
Condition | Intervention | Phase |
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Liver Transplantation |
Drug: Ambisome Procedure: Liver Biopsy |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Blood, Bile and Tissue Pharmacokinetics of Single Dose Liposomal Amphotericin B (AmBisome ®) in Liver Transplant Patients. |
Enrollment: | 10 |
Study Start Date: | September 2005 |
Study Completion Date: | December 2007 |
Fungal infections continue to be a source of serious morbidity and mortality in liver transplant patients. Liposomal Amphotericin B (AmBisome ®) has been shown in animals to be concentrated in the liver, lungs and leukocytes. It also has a long half-like making it a potentially attractive drug for prophylaxis in liver transplantation (OLT).
We propose to administer a single (5mg/kg) dose of AmBisome ® following reperfusion of the new liver. Liver, subcutaneous fat, blood and bile samples will be analyzed for AMB levels 1-2 hours after drug administration. Blood and bile, and body fluid samples will be sequentially analyzed for 3 weeks post transplant. This will be done in 50 consecutive patients. The incidence of fungal infections and adverse effects will be monitored for three months.
Persistent AMB levels in blood bile and ascites, if found, will provide a good rationale for AmBisome ® prophylaxis for fungal infections in outpatients.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Memorial Hermann Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Hadar J. Merhav, MD | The University of Texas Health Science Center, Houston |
Responsible Party: | Memorial Hermann Hospital ( Dr. Hadar Merhav ) |
Study ID Numbers: | HSC-MS-04-0347, Astellas Pharma, APUSprojectno.JK-04-001 |
Study First Received: | September 8, 2005 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00161356 |
Health Authority: | United States: Institutional Review Board |
Abelcet Amphotericin B Clotrimazole |
Miconazole Tioconazole Liposomal amphotericin B |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Antifungal Agents |
Therapeutic Uses Antibiotics, Antifungal Amebicides Pharmacologic Actions |