Ambisome in Liver Transplant Patients

Liver Transplantation Clinical Trial

Official title:

Blood, Bile and Tissue Pharmacokinetics of Single Dose Liposomal Amphotericin B (AmBisome ®) in Liver Transplant Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00161356
• Other study ID #: HSC-MS-04-0347
• Secondary ID: Astellas PharmaA
• Status: Terminated
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: June 20, 2008
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Ambisome
5mg/kg IV - one time dose during liver transplant

Procedure:
• Liver Biopsy
post drug delivery (60 min. after completion of Ambisome infusion)

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue concentration of ambisome		3 months	Yes
Primary	Bile levels of amphotericin B over time (3 weeks)		3 weeks	No
Primary	Blood levels of amphotericin B over time (3 weeks)		3 weeks	No
Secondary	Rate of fungal infections		3 months	No