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

Liver Carcinoma Clinical Trial

Official title:

De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma: Long-Term Outcomes and Side Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328770
• Other study ID #: #4279
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 19, 2006
• Last updated: June 18, 2013
• Start date: December 1996
• Est. completion date: March 2006

Study information

• Verified date: June 2013
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion criteria:

• Patients less than 18 years of age

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Carcinoma

Intervention

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

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Surviving at One and Four Years After Liver Transplant	Percent of Patients Surviving at One & Four years after Liver Transplant was calculated	1 & 4 years	No
Primary	Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant	Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant	1 and 4 years	No
Secondary	Sirolimus Toxicity/Intolerance	Sirolimus toxicity/intolerance requiring discontinuation of sirolimus	1 year	Yes