A Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation

NCT00166556 | Completed Phase 2

• 1 other identifier: 2355-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 stage liver disease who meets the entry criteria will be consented and enrolled. Participants receive Campath-1H and maintenance immunosuppression with tacrolimus therapy. After one year of tacrolimus therapy, an assessment of the immunologic status including blood gene expression and geno-race studies will be performed which will include studies on the liver graft biopsy. At this time, patients will be selected to undergo immunosuppressive withdrawal. This will be made on an individual basis with definitive inclusion and exclusion criteria. The objectives of the study are to evaluate the safety and efficacy of immunosuppressive regimens comprising Campath-1H induction followed by maintenance immunosuppressive therapy with tacrolimus on allograft survival. However, secondary objectives will be to assess withdrawing tacrolimus after Campath-1H induction in an immune depletion and subsequent immune reconstitution. This study will evaluate whether a combination of anti-rejection medications (Campath-1H and tacrolimus) can prevent rejection and allow the body to develop tolerance to the transplanted liver.

Conditions

Transplantation, Liver

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and efficacy of an immunosuppression regimen comprising Campath-1H induction followed by maintenance therapy with tacrolimus in allowing liver allograft survival

Secondary Outcomes (3)

• Assess the safety of withdrawing tacrolimus after Campath-1H induced immuno-depletion and subsequent immune reconstitution

• Gather additional safety information about the combination of Campath-1H and tacrolimus in liver allograft recipients

• Define profiles of immunologic and genetic features present prior to or during tapering of immunosuppression that distinguish tolerant and non tolerant allograft recipients

Interventions

Campath-1H and Tacrolimus DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Chicago: collaborator
• Immune Tolerance Network (ITN): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Alemtuzumab; Tacrolimus

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Russell H. Wiesner, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 23, 2011

Record last verified: 2011-05

Locations

US (1)