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This study has been withdrawn prior to enrollment.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

December 14, 2007
February 20, 2009
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Complete list of historical versions of study NCT00849238 on ClinicalTrials.gov Archive Site
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Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation
Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Liver Transplant
Drug: mycophenolate mofetil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00849238
2005-0291, CEL
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University of Wisconsin, Madison
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University of Wisconsin, Madison
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP