Status:
COMPLETED
Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Liver Disease
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 org...
Detailed Description
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 de...
Eligibility Criteria
Inclusion
- Diagnosis of nonimmune, nonviral, end-stage liver disease
- Need liver transplant
- Willing to use acceptable means of contraception for the duration of the study
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00105235
Start Date
June 1 2005
End Date
March 1 2011
Last Update
December 27 2012
Active Locations (9)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
University of Colorado
Denver, Colorado, United States, 80262
3
University of Miami School of Medicine
Miami, Florida, United States, 33101
4
University of Michigan
Ann Arbor, Michigan, United States, 48109