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Ambisome in Liver Transplant Patients

NCT ID: NCT00161356

Last Updated: 2008-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Ambisome

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

Intervention Type DRUG

Liver Biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Memorial Hermann Hospital

Principal Investigators

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Hadar J. Merhav, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Memorial Hermann Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Astellas Pharma

Identifier Type: -

Identifier Source: secondary_id

APUSprojectno.JK-04-001

Identifier Type: -

Identifier Source: secondary_id

HSC-MS-04-0347

Identifier Type: -

Identifier Source: org_study_id