Optimization of tacrolimus dose regimen in pediatric living donor livertransplantation.

• Conditions: PEDIATRIC LIVER TRANSPLANTATION; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-000615-24-BE
• Lead Sponsor: Cliniques universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-07
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children aged 0 to 18 years old
First liver transplant
Patient eligible to receive tacrolimus post transplant
Parents' approval to participate

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Multiorgan transplantation
ABO incompatible patients (unless aged less than 1 year and AB antibody <1/32)
Retransplantation
Multi organ failure
Introduction of tacrolimus administration postponed after day 3 post transplantation
Need for additional steroid therapy except methylprednisolone to treat rejection
Need for intraveinous tacrolimus
Consent refusal or incapacity to understand the study procedures
Retransplantation
Multiorgan transplantation
Introduction of tacrolimus administration postponed after

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified