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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238901

Enrollment

194

Registered

2005-10-14

Start date

2002-12-31

Completion date

Unknown

Last updated

2010-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant

Keywords

Liver transplant, HCV+, steroid free

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.

Interventions

DRUGBasiliximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
12-month cumulative incidence of post-surgical graft loss and death	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026