Pharmacokinetic of Tacrolimus in Paediatric Liver Transplant Patients

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Age of children who need to have a liver transplantation : between 6 month and 12 years

• Formulary of consent signed by the two parents.

• Children who need to receive tacrolimus per os (Modigraf® ) only after liver transplantation associated to Simulect® (basilixumab) in post-transplantation immediately as main

• Affiliation to the system of social protection.

Exclusion Criteria:

• Children who need a multi organs transplantation

• Hypersensibility or Contraindication to Modigraf® or others macrolides.

• Patients retransplanted in the 14 days after the transplantation

• Patients with multivisceral failure

• Patients who have an introduction of tacrolimus 3 days after transplantation

• Patients who need complementary immunosuppressive drugs with corticoids excepted methylprednisolone used for reject

• Patients who received Prograf® per os or iv.

• Patients who received Cellcept® or Myfortic®

• Opposition to sign the formulary of consent or the understand the note of information