Status:
COMPLETED
A Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
University of Chicago
Immune Tolerance Network (ITN)
Conditions:
Transplantation, Liver
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a prospective, multicenter open-label single arm trial in which recipients of liver allograft will receive uniform immunosuppressive induction and maintenance regimens. Participants with end s...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older
- Necessity for liver transplant
- A negative pregnancy test at study entry for females of child-bearing potential
- For participants with reproductive potential, agreement to use approved methods of birth control for the duration of their participation
- Ability to provide informed consent
- Availability of donor spleen
Exclusion
- Previous transplant
- Multiorgan transplant
- Living donor transplant.
- Donor liver from a donor positive for antibody against hepatitis B core antigen
- Donor liver from a donor positive for antibody against hepatitis C
- Donor liver from a non-heart-beating donor
- Liver failure due to autoimmune disease, such as autoimmune hepatitis, primary sclerosing cholangitis, and primary biliary cirrhosis
- Hepatitis B infection as defined by the presence of HbSAg or active treatment for hepatitis B
- Hepatitis C as defined by the presence of antibody against hepatitis C.
- Stage III or higher hepatocellular cancer based on pretransplant imaging
- History of malignancy except hepatocellular cancer, or adequately treated in situ cervical carcinoma, adequately treated basal or squamous cell carcinoma of skin, or other malignancy which is judged to have a 5-year risk of recurrence of \< 5%
- Active systemic infection at the time of transplantation
- Clinically significant chronic renal disease
- Clinically significant cardiovascular or cerebrovascular disease
- Infection with human immunodeficiency virus
- Any investigational drug received within 6 weeks of study entry
- Hypersensitivity to Campath-1H or tacrolimus
- Unwillingness or inability to comply with study requirements (Immune Tolerance Network CONFIDENTIAL iv Protocol ITN024ST Immunosuppression with Campath-1H Version 3.0 June 28, 2005 and Tacrolimus in Liver Transplantation)
- Inability to give appropriate informed consent (e.g., hepatic encephalopathy stage 2 or higher at time of screening consent)
- Positive PPD without evidence of prior treatment or administration of BCG
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00166556
Start Date
January 1 2005
End Date
December 1 2006
Last Update
May 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905