Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation

Phase 3

Completed

• Conditions: Liver Transplant

• Registration Number: NCT00238901
• Lead Sponsor: Novartis

Brief Summary

The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems.

The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2005-07
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-14
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-31
• Last Update Posted: 2010-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
12-month cumulative incidence of post-surgical graft loss and death

Secondary Outcome Measures

Name	Time	Method
hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery.
treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery.
graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months.
viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation.