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

NCT ID: NCT00328770

Last Updated: 2013-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sirolimus based immunosuppression

Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l

Interventions

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Sirolimus

Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l

Intervention Type DRUG

Other Intervention Names

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Rapamune

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients less than 18 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Norman Kneteman

Co-zone Clinical Section Chief, Transplants/NARP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman M Kneteman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247.

Reference Type DERIVED
PMID: 19192962 (View on PubMed)

Other Identifiers

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#4279

Identifier Type: -

Identifier Source: org_study_id

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