Pharmacokinetic of Tacrolimus in Paediatric Liver Transplant Patients

NCT02337036 | Unknown DMC

• 2 other identifiers: P1209042013-000948-26
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liver transplantation; Child; Tacrolimus; Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• Blood concentration of tacrolimus (ng/mL)

  Residual concentration, Cmin, Cmax, Cl/F and Area Under the Curve of tacrolimus (AUC)

  Between day2 and day4 and day 10 and day14, after day 21

Secondary Outcomes (4)

• "P3A5" cytochrome (CYP3A5/4), "ABCB1" genotypes of donor and recipient.

  Up to 3 years

• Factor V and prothrombin time

  Up to 3 years

• Time to achieve two concentrations of tacrolimus in the therapeutic target without change of posology

  Up to 3 years

• Clinical Occurrence of adverse events (reject and/or adverse effects with tacrolimus)

  Up to 3 years

Study Arms (1)

Arm 1: Pharmacokinetic and Pharmacogenetic

EXPERIMENTAL

Liver Transplant Children treated with tacrolimus

Other: Pharmacokinetic; Other: Pharmacogenetic; Drug: Tacrolimus

Interventions

Pharmacokinetic OTHER

Taking blood samples for an Pharmacokinetic of tacrolimus in Paediatric Liver Transplant Patients treated with tacrolimus

Arm 1: Pharmacokinetic and Pharmacogenetic

Pharmacogenetic OTHER

Pharmacogenetic study

Arm 1: Pharmacokinetic and Pharmacogenetic

Tacrolimus DRUG

These Patients are treated with tacrolimus after the Liver Transplantation

Arm 1: Pharmacokinetic and Pharmacogenetic

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

RECRUITING

MeSH Terms

Interventions

Pharmacogenomic Variants; Pharmacogenomic Testing; Tacrolimus

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Macrolides; Lactones; Organic Chemicals

Study Officials

• Emmanuel GONZALES, PhD, MD

  AP-HP, Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VERSTUYFT Céline, PhD, PharmD

CONTACT

+33 (0)1 45 21 35 88; celine.verstuyft@bct.aphp.fr

Emmanuel GONZALES, PhD, MD

CONTACT

+33 (0)1 45 21 21 21; emmanuel.gonzales@bct.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: January 13, 2015
• Study Start: December 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

FR (1)