Ambisome in Liver Transplant Patients

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• All adult liver transplant recipients receiving cadaveric liver transplants

Exclusion Criteria:

• Patients with choledocho-jejunostomy reconstruction of the biliary tree.

• Children less than 18 years of age

• Patients with known allergy to Amphotericin B.