Pharmacokinetic of Tacrolimus in Paediatric Liver Transplant Patients (TACTHEP)
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|ClinicalTrials.gov Identifier: NCT02337036|
Recruitment Status : Unknown
Verified October 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : January 13, 2015
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation, Child||Other: Pharmacokinetic Other: Pharmacogenetic Drug: Tacrolimus||Not Applicable|
Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its use is complicated by its narrow therapeutic index and variable pharmacokinetics. Therapeutic drug monitoring (TDM) of tacrolimus, based on whole-blood trough concentration (C0) values, is mandatory for use of twice-daily tacrolimus (Prograf_) as in order to decrease interindividual variability in exposure and thereby minimize the risk of acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser extent, neurotoxicity).
Until now, the C0 is the easiest means of individual dose adjustment, as only one blood sample is required and the clinician can easily calculate the dose needed to reach the target. Many factors have an impact on the pharmacokinetic parameters. However the adaptation of the time to achieve the target stays an issue. Among factors of inter and intra variability of pharmacokinetic of tacrolimus, some of them are specific of the pediatric liver transplantation population.
Aims: To build a population pharmacokinetic model that describes the apparent clearance of tacrolimus and the potential demographic, clinical and genetically controlled factors that could lead to inter-patient pharmacokinetic variability within children following liver transplantation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Building a Population Pharmacokinetic Model of Tacrolimus in Paediatric Liver Transplant Patients|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Arm 1: Pharmacokinetic and Pharmacogenetic
Liver Transplant Children treated with tacrolimus
Taking blood samples for an Pharmacokinetic of tacrolimus in Paediatric Liver Transplant Patients treated with tacrolimus
These Patients are treated with tacrolimus after the Liver Transplantation
- Blood concentration of tacrolimus (ng/mL) [ Time Frame: Between day2 and day4 and day 10 and day14, after day 21 ]Residual concentration, Cmin, Cmax, Cl/F and Area Under the Curve of tacrolimus (AUC)
- "P3A5" cytochrome (CYP3A5/4), "ABCB1" genotypes of donor and recipient. [ Time Frame: Up to 3 years ]
- Factor V and prothrombin time [ Time Frame: Up to 3 years ]To estimate a delayed graft function
- Time to achieve two concentrations of tacrolimus in the therapeutic target without change of posology [ Time Frame: Up to 3 years ]
- Clinical Occurrence of adverse events (reject and/or adverse effects with tacrolimus) [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337036
|Contact: VERSTUYFT Céline, PhD, PharmD||+33 (0)1 45 21 35 email@example.com|
|Contact: Emmanuel GONZALES, PhD, MD||+33 (0)1 45 21 21 firstname.lastname@example.org|
|AP-HP, Bicêtre Hospital||Recruiting|
|Le Kremlin-Bicêtre, France, 94275|
|Contact: Emmanuel GONZALES, PhD, MD +33 (0)1 45 21 21 21 email@example.com|
|Contact: Celine Verstuyft, PhD, PharmD +33 (1) 45 21 35 88 firstname.lastname@example.org|
|Principal Investigator:||Emmanuel GONZALES, PhD, MD||AP-HP, Bicêtre Hospital|