A Phase 4 interventional study of Ambisome and Liver Biopsy in Liver Transplantation, sponsored by The University of Texas Health Science Center, Houston. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-06-23.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Prevention
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.
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.
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5mg/kg IV - one time dose during liver transplant
post drug delivery (60 min. after completion of Ambisome infusion)
Tissue concentration of ambisome
Time frame: 3 months
Bile levels of amphotericin B over time (3 weeks)
Time frame: 3 weeks
Blood levels of amphotericin B over time (3 weeks)
Time frame: 3 weeks
Rate of fungal infections
Time frame: 3 months
This study is terminated, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston