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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238901
First Posted: October 14, 2005
Last Update Posted: September 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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:


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.

Enrollment: 194
Study Start Date: December 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238901


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00238901     History of Changes
Other Study ID Numbers: CCHI621AIT06
First Submitted: October 12, 2005
First Posted: October 14, 2005
Last Update Posted: September 1, 2010
Last Verified: August 2010

Keywords provided by Novartis:
Liver transplant, HCV+, steroid free

Additional relevant MeSH terms:
Basiliximab
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs