NCT00161356

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 23, 2008

Status Verified

June 1, 2008

First QC Date

September 8, 2005

Last Update Submit

June 20, 2008

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (3)

  • Tissue concentration of ambisome

    3 months

  • Bile levels of amphotericin B over time (3 weeks)

    3 weeks

  • Blood levels of amphotericin B over time (3 weeks)

    3 weeks

Secondary Outcomes (1)

  • Rate of fungal infections

    3 months

Interventions

AmbisomeDRUG

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

Liver BiopsyPROCEDURE

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult liver transplant recipients receiving cadaveric liver transplants

You may not qualify if:

  • Patients with choledocho-jejunostomy reconstruction of the biliary tree.
  • Children less than 18 years of age
  • Patients with known allergy to Amphotericin B.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

liposomal amphotericin B

Study Officials

  • Hadar J. Merhav, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2007

Last Updated

June 23, 2008

Record last verified: 2008-06

Locations

US(1)