Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161356
Status:
TERMINATED
Last Update Posted:
2008-06-23
First Post:
2005-09-08
Brief Title:
Ambisome in Liver Transplant Patients
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Blood Bile and Tissue Pharmacokinetics of Single Dose Liposomal Amphotericin B AmBisome in Liver Transplant Patients
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Budget issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 5mgkg 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
We propose to administer a single 5mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| APUSprojectnoJK-04-001 | None | None | None |
| Astellas Pharma | None | None | None |