AN OPEN, RANDOMISED, MULTICENTRE, CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS AND MINIMAL STEROIDS IN COMBINATION WITH EITHER A MONOCLONAL ANTI-IL2R ANTIBODY (DACLIZUMAB) OR MYCOPHENOLATE MOFETIL IN LIVER ALLOGRAFT TRANSPLANTATION - Marsilea (Mycophenolate mofetil or Antibodies with Reduced Steroids in Liver transplantation)

Phase 1

Conditions: Patients with hepatic disease who will undergo primary orthotopic liver or split liver allograft transplantation.
MedDRA version: 7.0Level: LLTClassification code 10019650

Registration Number: EUCTR2004-001617-34-ES

Lead Sponsor: Fujisawa GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1.Male or female patients of any race, 18 years of age or older.
2.Patient is undergoing orthotopic liver or split liver allograft transplantation.
3.Female patient of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study.
4.Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed by an independent person.

Are the trial subjects under 18? no
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

1.Recipient of multi-organ transplant or previous organ transplant (including liver re-transplantation).
2.Recipient of an auxiliary graft or in whom a bio-artificial liver has been used.
3.Patient is receiving a living related liver transplantation.
4.Patient is receiving AB0 incompatible graft or a graft from a non heart beating donor.
5.Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s) or prohibited medication (see Section 7.6 of protocol).
6.Patient is requiring ongoing dosing with corticosteroids.
7.Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:
•< 3 nodes
•no node larger than 5 cm
•no metastases
•no vascular tumoral invasion
8.Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
9.Patient or donor is known to be HIV positive.
10.Patient is known to be allergic or intolerant to steroids, macrolide antibiotics, tacrolimus, daclizumab, mycophenolate mofetil and mycophenolic acid or to the excipients of the study medication.
11.Patient is pregnant or breast-feeding.
12.Patient has been previously enrolled in this study.
13.Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days.
14.Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator.
15.Patient is unlikely to comply with the visits scheduled in the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the efficacy and safety of two regimens (Arm 1 and Arm 2) containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.<br><br>Arm 1: Tacrolimus + MAB (daclizumab) + i.v. steroid bolus peri-op.<br>Arm 2: Tacrolimus + MMF (2g i.v. 3-5 days, 2g p.o. until day 14, thereafter 1g maintenance) + i.v. steroid bolus peri- op.<br>;Secondary Objective: None;Primary end point(s): The primary end point is the incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation.<br>

Secondary Outcome Measures

Name	Time	Method

Related Trials