E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
graft and patient survival at 12 monthd post-transplantation |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
compare within this patient cohort the evolution of hepatitis C positive and negative patients |
|
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |