Studying the possibility of tolerance induction in adult liver transplantation adding one single dose of polyclonal antilymphocytic antibodies to an calcineurin -inhibitor based immunosuppression using tacrolimus.
Conditions
Interventions
Trade Name: R- ATG
Product Name: R-ATG
Product Code: TACATG
Pharmaceutical Form: Intravenous infusion
CAS Number: 8000079949
Current Sponsor code: TACATG
Other descriptive name: IMMUNOGLOBULINS
Concen
Sponsors
UNIVERSITY HOSPITALS ST LUC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: One hundred adult patients will be enrolled. 1. The patient (male or female) must not be less than 15 years of age 2. Post-mortem or living donor liver allograft recipients undergoing their first transplantation 3. If female of childbearing potential, the patient must have practiced a medically approved form of contraception for a minimum of 30 days prior to study entry, and must continue to do so for the duration of the study treatment. 4. The patient or his/her guardian must voluntarily sign an Ethics Committee-approved informed consent form for entry into this study after the contents of that document have been fully explained Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients undergoing liver allograft re-transplantation 2) Patients who have undergone a previous organ transplantation 3) Patients with advanced (stage III – IV – VICC) neoplastic disease. 4) Patients with ABO incompatibility to the donor 5) Patients with autoimmune hepatitis 6) Patients who have received an investigational drug within 30 days of entry into this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Studying the possibility of immunosuppression withdrawal in an adult liver transplant population by introducing perioperative use of high-dose polyclonal antilymphocytic antibodies added to CNI)inhibitors;Secondary Objective: graft and patient survival at 12 monthd post-transplantation;Primary end point(s): The primary objectives of this pilot study are to study safety and efficacy of rapid tapering (within 12 months) to minimization Tacrolimus monotherapy in primary liver allograft recipients pre-treated with a high dose ATG infusion administered immediately before transplantation. Secondary objective will include determination of phenotype of mononuclear cell infiltrate and their cytokine production into the graft in order to look at eventual tolerogenic pathway. | — |
Countries
Belgium
Outcome results
None listed