Status:
COMPLETED
Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
Lead Sponsor:
University of Regensburg
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma...
Detailed Description
There are two major issues to face in patients who underwent liver transplantation for hepatocellular carcinoma (HCC). First, the patient requires adequate immunosuppressive medication to avoid reject...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Histologically proven HCC before randomisation
- Signed, written informed consent
Exclusion
- Multiple-organ recipients.
- Known hypersensitivity to sirolimus or its derivatives.
- Hyperlipidemia refractory to optimal medical management. (cholesterol \>300 mg/dL; triglycerides \>350 mg/dL).\*
- Evidence of significant local or systemic infection.
- Known HIV-positive patients.\*
- Platelets \<75,000/cubic mm.\*
- Women of child-bearing potential not willing to take contraception.
- Patients with non-HCC malignancies within the past 5 years,excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin.
- Extrahepatic HCC tumor manifestation
- Patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT00355862
Start Date
January 1 2006
End Date
May 1 2014
Last Update
July 30 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Regensburg University
Regensburg, Bavaria, Germany, 93053