A PROSPECTIVE RANDOMISED, OPEN-LABELED, TRIAL COMPARING SIROLIMUS-CONTAINING VERSUS MTOR-INHIBITOR-FREE IMMUNOSUPPRESSION IN PATIENTS UNDERGOING LIVER TRANSPLANTATION FOR HEPATOCELLULAR CARCINOMA - SILVER
- Conditions
- Prophylaxis against liver transplant rejection in patients undergoing liver transplantation for hepatocellular carcinoma HCCMedDRA version: 6.1Level: PTClassification code 10019695
- Registration Number
- EUCTR2005-005362-36-IT
- Lead Sponsor
- REGENSBURG UNIVERSITY MEDICAL CENTRE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 525
1. Age 18 years 2. Histologically proven HCC before randomisation 3. Signed, written informed consent
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
1. Multiple-organ recipients 2. Known hypersensitivity to sirolimus or its derivates 3. Hyperlidemia refractory to optimal medical management 4. Evidence of significant local or systemic infection 5. Known HIV-positive patients 6. Platelets 75.000/cubic mm 7. Women of child-bearing potential not willing to take contraception 8. Patients with non-HCC malignancies within the past 5 years excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method