Overview

Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Immune Tolerance Network (ITN)
Treatments:
Alemtuzumab
Cyclosporine
Cyclosporins
Liver Extracts
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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