Patients with hepatic disease who will undergo primary orthotopic liver or split liver allograft transplantation. MedDRA version: 7.0 Level: LLT Classification code 10019650
Conditions
Interventions
Trade Name: Prograf® 0.5 mg Capsules
Product Name: Prograf
Product Code: FK506
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Current Sponsor code: FK506
Co
Sponsors
Astellas Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Arm 1: Tacrolimus + MAB (daclizumab) + i.v. steroid bolus peri-op. 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. ;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. | — |
Countries
Belgium, Denmark, Finland, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed