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Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00849238
Recruitment Status : Withdrawn (feasibility issues)
First Posted : February 23, 2009
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment
Primary Liver Transplant Drug: mycophenolate mofetil

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction






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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00849238     History of Changes
Other Study ID Numbers: H-2005-0291
CEL
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action