Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients
NCT ID: NCT00105235
Last Updated: 2012-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2005-06-30
2011-03-31
Brief Summary
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Detailed Description
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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 Regimens that are less toxic to or can eventually be withdrawn from transplant recipients are needed.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 This study will also determine if post-transplant tacrolimus therapy can be slowly and safely tapered off and withdrawn a year after transplant.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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alemtuzumab
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
Alemtuzumab
T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4
Cyclosporine
Oral immunosuppressant
Mycophenolate mofetil
Oral immunosuppressant
Tacrolimus
Oral immunosuppressant
Liver transplant
Occurs at study entry
Immunosuppression withdrawal
Beginning no earlier than Year 1
Interventions
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Alemtuzumab
T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4
Cyclosporine
Oral immunosuppressant
Mycophenolate mofetil
Oral immunosuppressant
Tacrolimus
Oral immunosuppressant
Liver transplant
Occurs at study entry
Immunosuppression withdrawal
Beginning no earlier than Year 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Need liver transplant
* Willing to use acceptable means of contraception for the duration of the study
Exclusion Criteria
* Multiorgan transplant or living donor transplant
* Donor liver from a donor positive for antibody against hepatitis B core antigen or hepatitis C virus
* Donor liver from a non-heart-beating donor
* Liver failure due to autoimmune disease, such as autoimmune hepatitis, primary sclerosing cholangitis, or primary biliary cirrhosis
* Hepatitis B or C virus infection
* HIV infection
* Stage III or higher hepatocellular cancer based on pre-transplant imaging
* History of cancer. Patients with hepatocellular cancer, adequately treated in situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of skin are not excluded.
* Active systemic infection at the time of transplantation
* Clinically significant chronic renal, cardiovascular, or cerebrovascular disease
* Any investigational drug within 6 weeks of study entry
* Hypersensitivity to alemtuzumab or tacrolimus
18 Years
ALL
No
Sponsors
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Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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J. Richard Thistlethwaite, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of California, San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
University of Miami School of Medicine
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor University
Dallas, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Alberta
Edmonton, Alberta, Canada
Countries
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References
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First MR. Tacrolimus based immunosuppression. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S25-31.
Tryphonopoulos P, Madariaga JR, Kato T, Nishida S, Levi DM, Moon J, Selvaggi G, De Faria W, Regev A, Bejarano P, Khaled A, Safdar K, Esquenazi V, Weppler D, Yoshida H, Ruiz P, Miller J, Tzakis AG. The impact of Campath 1H induction in adult liver allotransplantation. Transplant Proc. 2005 Mar;37(2):1203-4. doi: 10.1016/j.transproceed.2004.12.157.
Tzakis AG, Tryphonopoulos P, Kato T, Nishida S, Levi DM, Madariaga JR, Gaynor JJ, De Faria W, Regev A, Esquenazi V, Weppler D, Ruiz P, Miller J. Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation. Transplantation. 2004 Apr 27;77(8):1209-14. doi: 10.1097/01.tp.0000116562.15920.43.
Related Links
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Click here for the Immune Tolerance Network Web site
Other Identifiers
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DAIT ITN024ST
Identifier Type: -
Identifier Source: org_study_id