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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00105235 |
Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a drug used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected. This study will determine whether treatment with alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.
Condition | Intervention | Phase |
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Liver Disease Liver Transplantation |
Drug: Alemtuzumab Drug: Cyclosporine Drug: Mycophenolate mofetil Drug: Tacrolimus Procedure: Liver transplant Procedure: Immunosuppression withdrawal |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Multicenter Trial to Assess the Safety and Efficacy of Campath-1H and Tacrolimus Followed By Immunosuppression Withdrawal in Liver Transplantation |
Enrollment: | 27 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | March 2011 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Liver transplant, with two in-patient infused doses of alemtuzumab; followed by maintenance immunotherapy with cyclosporine, mycophenolate mofetil, and/or tacrolimus; with possible immunosuppression withdrawal
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Drug: Alemtuzumab
T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4
Drug: Cyclosporine
Oral immunosuppressant
Drug: Mycophenolate mofetil
Oral immunosuppressant
Drug: Tacrolimus
Oral immunosuppressant
Procedure: Liver transplant
Occurs at study entry
Procedure: Immunosuppression withdrawal
Beginning no earlier than Year 1
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Organ transplantation is a common procedure in hospitals, but organ rejection and serious side effects are potential problems for the patient. Alemtuzumab is a monoclonal antibody that binds to and depletes excess T cells in the bone marrow of leukemia patients. In this study, alemtuzumab will destroy the recipient's white blood cells (WBCs) at the time of transplantation. It is hoped that WBCs produced after alemtuzumab administration will recognize the transplanted liver as "self" and not reject the new liver.
Drugs that suppress the immune system, such as tacrolimus, have contributed to increased success of transplantation. However, to prevent organ rejection, transplant recipients need to take immunosuppressive drugs for the rest of their lives, and these drugs make patients more susceptible to infection, endangering their health and survival. Regimens that are less toxic to or can eventually be withdrawn from transplant recipients are needed. This study will evaluate the effects of two in-patient doses of alemtuzumab followed by maintenance antirejection medication given to liver transplant patients post-transplant. This study will also determine if post-transplant tacrolimus therapy can be slowly and safely tapered off and withdrawn a year after transplant. Participants in this study will be patients with end-stage liver disease who will undergo liver transplantation at the start of the study.
This study will last at least 2 years. Patients will undergo liver transplantation at the start of the study on Day 0. Patients will receive in-patient infusions of alemtuzumab on Days 0 and 4. Starting on Day 1, patients will receive oral cyclosporine, mycophenolate mofetil, and/or tacrolimus daily. Patients will be hospitalized for at least 1 week after transplantation. Because of suppression of patients' immune systems by alemtuzumab and these other immunosuppressants, they will also receive prophylactic medications for a minimum of 3 months after transplantation to prevent opportunistic infections.
There will be at least eight study visits; they will occur at Days 4, 7, and 14 and at Months 1, 3, 6, 9, and 12. Patients will have liver biopsies at Day 0 and Months 6 and 12. At Month 12, participants will have assessments and blood tests to determine if they meet certain criteria and are eligible to undergo tacrolimus tapering. Patients eligible for tapering will undergo a 12-month gradual withdrawal of tacrolimus; they will be followed for an additional 2 years, with study visits at Months 18, 24, 30, and 36. Patients ineligible for tacrolimus tapering will continue taking their antirejection medication for the duration of the study; they will be followed for an additional year, with study visits at Months 18 and 24.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80262 | |
United States, Florida | |
University of Miami School of Medicine | |
Miami, Florida, United States, 33101 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Baylor University | |
Dallas, Texas, United States, 75246 | |
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 | |
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada |
Principal Investigator: | J. Richard Thistlethwaite, MD | University of Chicago |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN024ST |
Study First Received: | March 10, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00105235 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
transplantation liver transplant rejection tolerance antibody induction |
Liver Diseases Cyclosporine Clotrimazole Miconazole Tioconazole Tacrolimus Cyclosporins |
Antibodies, Monoclonal Antibodies Digestive System Diseases Alemtuzumab Mycophenolate mofetil Immunoglobulins |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antifungal Agents |
Physiological Effects of Drugs Enzyme Inhibitors Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Pharmacologic Actions |