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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00238901 |
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 |
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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) |
Estimated Enrollment: | 190 |
Study Start Date: | December 2002 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
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 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 |
Liver transplant, HCV+, steroid free |
Virus Diseases Hepatitis Basiliximab Cyclosporine Immunologic Factors |
Mycophenolate mofetil Hepatitis C Immunosuppressive Agents Cyclosporins |
Basiliximab Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |