NCT00328770

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Liver Carcinoma

Interventions

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

Timeline

• Start date: 1996-12-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2006-05-22
• Last updated: 2013-06-24
• Results posted: 2012-10-01

Locations

1 site across 1 country: Canada