Ambisome in Liver Transplant Patients | NCT00161356

Studies
Ambisome in Liver Transplant Patients

NCT00161356

Sponsor

The University of Texas Health Science Center, Houston

Status

Terminated

Last Update Posted

Jun 23, 2008Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Liver Transplantation

Interventions

Ambisome
Liver Biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Budget issues

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2008

Last Update Posted Date

Jun 23, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ambisome	Drug	5mg/kg IV - one time dose during liver transplant
Liver Biopsy	Procedure	post drug delivery (60 min. after completion of Ambisome infusion)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Rate of fungal infections		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hadar J. Merhav, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Hermann Hospital		Houston	Texas	77030	United States

Intervention Browse Module

MeSH Terms

ID	Term
C068538	liposomal amphotericin B

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
Astellas Pharma
APUSprojectno.JK-04-001