Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

This study has been withdrawn prior to enrollment.
(feasibility issues)
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00849238
First received: December 14, 2007
Last updated: February 20, 2009
Last verified: February 2009
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

  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

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

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

ClinicalTrials.gov processed this record on April 22, 2014