This study is to examine whether the combination of a low dose of a new drug Sirolimus in combination with a low dose of the standard anti-rejection medication Tacrolimus is safer and works equally well in patients after liver transplantation.

Phase 1

• Conditions: iver transplantation; MedDRA version: 19.0Level: LLTClassification code 10050434Term: Prophylaxis against liver transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2009-017843-32-NL
• Lead Sponsor: Foundation of Liver Research (SLO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-29
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

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

Inclusion Criteria

•Primary liver transplantation or retransplantation within 14 days after first transplantation
•Use of Advagraf at least 2 weeks prior to randomization
•Patent hepatic artery
•Closed abdominal wound
•Stable graft function
•Positive informed consent at time of randomization
•Age 18-70 years

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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

•Treatment with investigational drugs within 3 months before start of therapy
•Multi organ transplantation
•cGFR < 30 ml/min
•Proteinuria > 800 mg/24 h
•Hypersensitivity to sirolimus
•Thrombocytes < 50 x 109 /L
•Leukocytes < 2.5 x 109 /L
•Haemoglobin < 6 mmol/L
•Biopsy proven rejection 2 weeks prior to randomization
•HIV positivity
•Signs of recurrent or de novo cancer
•Pregnancy or breast feeding
•Systemic infection
•Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study

Study & Design

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