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

This study has been completed.
Sponsor:
Collaborators:
University of Chicago
Immune Tolerance Network (ITN)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166556
First received: September 12, 2005
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Transplantation, Liver
Drug: Campath-1H and Tacrolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thistlethwaite Protocol # ITN025ST - Immunosuppression With Campath-1H and Tacrolimus in Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 10
Study Start Date: January 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18 years of age or older
  2. Necessity for liver transplant
  3. A negative pregnancy test at study entry for females of child-bearing potential
  4. For participants with reproductive potential, agreement to use approved methods of birth control for the duration of their participation
  5. Ability to provide informed consent
  6. Availability of donor spleen

Exclusion Criteria:

  1. Previous transplant
  2. Multiorgan transplant
  3. Living donor transplant.
  4. Donor liver from a donor positive for antibody against hepatitis B core antigen
  5. Donor liver from a donor positive for antibody against hepatitis C
  6. Donor liver from a non-heart-beating donor
  7. Liver failure due to autoimmune disease, such as autoimmune hepatitis, primary sclerosing cholangitis, and primary biliary cirrhosis
  8. Hepatitis B infection as defined by the presence of HbSAg or active treatment for hepatitis B
  9. Hepatitis C as defined by the presence of antibody against hepatitis C.
  10. Stage III or higher hepatocellular cancer based on pretransplant imaging
  11. 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%
  12. Active systemic infection at the time of transplantation
  13. Clinically significant chronic renal disease
  14. Clinically significant cardiovascular or cerebrovascular disease
  15. Infection with human immunodeficiency virus
  16. Any investigational drug received within 6 weeks of study entry
  17. Hypersensitivity to Campath-1H or tacrolimus
  18. 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)
  19. Inability to give appropriate informed consent (e.g., hepatic encephalopathy stage 2 or higher at time of screening consent)
  20. Positive PPD without evidence of prior treatment or administration of BCG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166556

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Chicago
Immune Tolerance Network (ITN)
Investigators
Principal Investigator: Russell H. Wiesner, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166556     History of Changes
Other Study ID Numbers: 2355-04
Study First Received: September 12, 2005
Last Updated: May 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tacrolimus
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014