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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norman Kneteman, University of Alberta
ClinicalTrials.gov Identifier:
NCT00328770
First received: May 19, 2006
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria:

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

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

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Norman Kneteman, Co-zone Clinical Section Chief, Transplants/NARP, University of Alberta
ClinicalTrials.gov Identifier: NCT00328770     History of Changes
Other Study ID Numbers: #4279
Study First Received: May 19, 2006
Results First Received: June 12, 2012
Last Updated: August 27, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
liver transplant
hepatocellular carcinoma
sirolimus

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sirolimus
 Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013