Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 7:46 PM
Study NCT ID:
NCT05277792
Status:
UNKNOWN
Last Update Posted:
2023-07-28
First Post:
2022-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STABILE 2
Brief Summary:
The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.
Detailed Description:
The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity.
A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.
A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: