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

Liver Transplant Clinical Trial

Official title:

Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238901
• Other study ID #: CCHI621AIT06
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2005
• Last updated: August 31, 2010
• Start date: December 2002

Study information

• Verified date: August 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months)

Exclusion Criteria Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Drug:
• Basiliximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month cumulative incidence of post-surgical graft loss and death
Secondary	hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery.
Secondary	treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery.
Secondary	graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months.
Secondary	viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation.