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De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

This study has been completed.
Information provided by (Responsible Party):
Norman Kneteman, University of Alberta Identifier:
First received: May 19, 2006
Last updated: June 18, 2013
Last verified: June 2013
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

Condition Intervention Phase
Liver Carcinoma
Drug: Sirolimus
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma: Long-Term Outcomes and Side Effects

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Percentage of Participants Surviving at One and Four Years After Liver Transplant [ Time Frame: 1 & 4 years ]
    Percent of Patients Surviving at One & Four years after Liver Transplant was calculated

  • Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant [ Time Frame: 1 and 4 years ]
    Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant

Secondary Outcome Measures:
  • Sirolimus Toxicity/Intolerance [ Time Frame: 1 year ]
    Sirolimus toxicity/intolerance requiring discontinuation of sirolimus

Enrollment: 70
Study Start Date: December 1996
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sirolimus based immunosuppression
Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l
Drug: Sirolimus
Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
Other Name: Rapamune

Detailed Description:
A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant

Exclusion criteria:

  • Patients less than 18 years of age
  Contacts and Locations
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Please refer to this study by its identifier: NCT00328770

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Principal Investigator: Norman M Kneteman, MD University of Alberta
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Norman Kneteman, Co-zone Clinical Section Chief, Transplants/NARP, University of Alberta Identifier: NCT00328770     History of Changes
Other Study ID Numbers: #4279
Study First Received: May 19, 2006
Results First Received: June 12, 2012
Last Updated: June 18, 2013

Keywords provided by University of Alberta:
liver transplant
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017