Ambisome in Liver Transplant Patients - Full Text View

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00161356

Purpose

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
Liver Transplantation	Drug: Ambisome Procedure: Liver Biopsy	Phase IV

MedlinePlus related topics: Fungal Infections Liver Transplantation Molds

Drug Information available for: Amphotericin B

U.S. FDA Resources

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.

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Tissue concentration of ambisome [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Bile levels of amphotericin B over time (3 weeks) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Blood levels of amphotericin B over time (3 weeks) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of fungal infections [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	September 2005
Study Completion Date:	December 2007

Intervention Details:

5mg/kg IV - one time dose during liver transplant

post drug delivery (60 min. after completion of Ambisome infusion)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161356

Locations

United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

Hadar J. Merhav, MD

The University of Texas Health Science Center, Houston

More Information

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

Study placed in the following topic categories:

Abelcet
Amphotericin B
Clotrimazole

Miconazole
Tioconazole
Liposomal amphotericin B

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antifungal Agents

Therapeutic Uses
Antibiotics, Antifungal
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009