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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00328770
Recruitment Status : Completed
First Posted : May 22, 2006
Results First Posted : October 1, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
Norman Kneteman, University of Alberta

Study Description
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Brief Summary:
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

Condition or disease Intervention/treatment Phase
Liver Carcinoma Drug: Sirolimus Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma: Long-Term Outcomes and Side Effects
Study Start Date : December 1996
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 :
  1. Sirolimus Toxicity/Intolerance [ Time Frame: 1 year ]
    Sirolimus toxicity/intolerance requiring discontinuation of sirolimus


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328770


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Norman M Kneteman, MD University of Alberta
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Norman Kneteman, Co-zone Clinical Section Chief, Transplants/NARP, University of Alberta
ClinicalTrials.gov Identifier: NCT00328770    
Other Study ID Numbers: #4279
First Posted: May 22, 2006    Key Record Dates
Results First Posted: October 1, 2012
Last Update Posted: June 24, 2013
Last Verified: June 2013
Keywords provided by Norman Kneteman, University of Alberta:
liver transplant
hepatocellular carcinoma
sirolimus
Additional relevant MeSH terms:
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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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs