Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients
Completed · Phase 2
Conditions studied: Liver Disease, Liver Transplantation
In brief
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.
Key facts
- Study ID
- NCT00105235
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 27
- Starts
- 2005-06-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2012-12-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of nonimmune, nonviral, end-stage liver disease
- Need liver transplant
- Willing to use acceptable means of contraception for the duration of the study
You may not qualify if…
- Previous transplant
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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