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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00849238 |
The rationale for this study is to determine if Campath-1H can be used in liver transplant recipients to induce a state of immunological unresponsiveness that would not only eliminate the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the severity of histologic recurrence of certain autoimmune diseases responsible for causing liver failure. The investigator propose a randomized prospective open label trial in 50 liver transplant recipients who will received a calcineurin inhibitors free immunosuppressive protocol that consist of a single dose of Campath-1H as an induction therapy in association with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group will receive a standard immunosuppressive regimen, which consists of IV steroid induction therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no induction antibody therapy.
Condition | Intervention |
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Primary Liver Transplant |
Drug: mycophenolate mofetil |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction |
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2005-0291, CEL |
Study First Received: | December 14, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00849238 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Bacterial Agents Immunologic Factors Alemtuzumab |
Mycophenolic Acid Mycophenolate mofetil Immunosuppressive Agents |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Mycophenolic Acid |
Mycophenolate mofetil Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |