Pharmacokinetic of Tacrolimus in Paediatric Liver Transplant Patients
NCT02337036 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2020-09-01
Summary
Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its use is complicated by its narrow therapeutic index and variable pharmacokinetics. This study is designed to assess the posology of tacrolimus in post-transplantation in the month after liver transplantation to obtain a therapeutic target between 10-15 ng/mL and the impact of biological and genetic factors on the pharmacokinetic parameters in paediatric liver transplant recipients.
Conditions
- Liver Transplantation, Child
Interventions
- OTHER
-
Pharmacokinetic
Taking blood samples for an Pharmacokinetic of tacrolimus in Paediatric Liver Transplant Patients treated with tacrolimus
- OTHER
-
Pharmacogenetic
Pharmacogenetic study
- DRUG
-
These Patients are treated with tacrolimus after the Liver Transplantation
Sponsors & Collaborators
-
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Emmanuel GONZALES, PhD, MD · AP-HP, Bicêtre Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Months
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- France
Study Locations
More Related Trials
-
Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients
NCT00411944 ·Status: COMPLETED
-
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
NCT06183892 ·Status: RECRUITING ·Phase: NA
-
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
NCT05744635 ·Status: RECRUITING
-
Prevalence of CYP3A5 Polymorphisms in the Donors and ABCB1 Polymorphisms in the Recipients Undergoing Pediatric Liver Transplant and Their Influence on Tacrolimus Levels and Graft Function.
NCT06361732 ·Status: RECRUITING
-
Comparison of Immunosuppression Protocols After LTx in Children
NCT00195988 ·Status: COMPLETED ·Phase: PHASE4
-
Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
NCT03800576 ·Status: COMPLETED
-
Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors
NCT02608606 ·Status: COMPLETED ·Phase: NA
-
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
NCT00297310 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
NCT00987103 ·Status: UNKNOWN ·Phase: PHASE1
-
rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation
NCT01207141 ·Status: COMPLETED
-
Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity
NCT01709136 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
NCT01614665 ·Status: COMPLETED ·Phase: PHASE2
-
TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion
NCT01564095 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
NCT06147375 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The New LC-MS/MS Method for Determination of Unbound Tacrolimus in Plasma
NCT04657562 ·Status: UNKNOWN
-
Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients
NCT00608244 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing
NCT00028171 ·Status: COMPLETED ·Phase: NA
-
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
NCT00282243 ·Status: COMPLETED ·Phase: PHASE2
-
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
NCT02808065 ·Status: UNKNOWN
-
Study of PD/PK/PG Relationships of Tacrolimus and Cyclosporin in Liver Transplant Patients
NCT01760356 ·Status: TERMINATED
-
Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients
NCT00812786 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
NCT00909571 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
NCT05152628 ·Status: COMPLETED ·Phase: PHASE4
-
Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation
NCT00656266 ·Status: TERMINATED ·Phase: PHASE4
-
Study of the Cellular Diffusion of Tacrolimus Across the Membrane of Mononuclear Cells
NCT03654794 ·Status: COMPLETED