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Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation
This study has been withdrawn prior to recruitment.
( feasibility issues )
First Received: December 14, 2007   Last Updated: February 20, 2009   History of Changes
Sponsored by: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00849238
  Purpose

The rationale for this study is to determine if Campath-1H can be used in liver transplant recipients to induce a state of immunological unresponsiveness that would not only eliminate the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the severity of histologic recurrence of certain autoimmune diseases responsible for causing liver failure. The investigator propose a randomized prospective open label trial in 50 liver transplant recipients who will received a calcineurin inhibitors free immunosuppressive protocol that consist of a single dose of Campath-1H as an induction therapy in association with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group will receive a standard immunosuppressive regimen, which consists of IV steroid induction therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no induction antibody therapy.


Condition Intervention
Primary Liver Transplant
Drug: mycophenolate mofetil

Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects;
  2. Ages 45 years and older;
  3. Are to receive a liver transplant.

Exclusion Criteria:

  1. Recipients of a multi-organ transplant;
  2. known hypersensitivity to daclizumab, CellCept®, or prednisone;
  3. therapy with an investigational medication within 4 weeks of study entry;
  4. history of malignancies within the past 5 years and/or lymphoma, excluding adequately treated skin carcinoma (basal or squamous cell), or other than exclusion #9;
  5. history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
  6. history of HIV infection;
  7. females who are pregnant or nursing;
  8. subject is receiving systemic corticosteroids for other medical conditions for which the physician feels that discontinuation of corticosteroids is contraindicated;
  9. T2 or higher hepatocellular carcinoma
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Study ID Numbers: 2005-0291, CEL
Study First Received: December 14, 2007
Last Updated: February 20, 2009
ClinicalTrials.gov Identifier: NCT00849238     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Anti-Bacterial Agents
Immunologic Factors
Alemtuzumab
Mycophenolic Acid
Mycophenolate mofetil
Immunosuppressive Agents

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mycophenolic Acid
Mycophenolate mofetil
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 30, 2009