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Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma

NCT00355862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2014-07-30

No results posted yet for this study

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 (HCC), with regard to HCC recurrence-free patient survival.

Conditions

Interventions

DRUG

CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)

center specific therapeutic regimen without mTOR inhibition

DRUG

Sirolimus

Sirolimus based immunosuppression

Sponsors & Collaborators

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Edward K Geissler, Prof. PhD · Regensburg University Medical Center, Head of Experimental Surgery

  • Hans J Schlitt, Prof. MD. FACS FRACS FRCS MHM · Regensburg University Medical Center, Director of Surgical Department

  • Andreas A Schnitzbauer, MD · Regensburg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-04-30
Completion
2014-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00355862 on ClinicalTrials.gov