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

This study is ongoing, but not recruiting participants.

First Received: October 12, 2005 Last Updated: July 21, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00238901

Purpose

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.

Condition	Intervention	Phase
Liver Transplant	Drug: Basiliximab	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C Liver Transplantation Surgery

Drug Information available for: Basiliximab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	190
Study Start Date:	December 2002

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238901

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Study ID Numbers:	CCHI621AIT06
Study First Received:	October 12, 2005
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00238901 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Novartis:

Liver transplant, HCV+, steroid free

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Basiliximab
Cyclosporine
Immunologic Factors

Mycophenolate mofetil
Hepatitis C
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Basiliximab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009