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Myfortic Conversion Trial in OLT Recipients With GI Intolerance

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00619216
First received: February 7, 2008
Last updated: June 1, 2011
Last verified: June 2011
History of Changes
  Purpose

Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.


Condition Intervention
GI Disturbance
 Drug: Mycophenolic Acid (Myfortic)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mycophenolic Acid (Myfortic)
    Equimolar conversion from mycophenolate mofetil to mycophenolic acid
    Other Name: Cellcept; Myfortic
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Recipients of Orthotopic Liver Transplants

Criteria

Inclusion Criteria:

  • Recipients of orthotopic liver transplant at least 8 weeks post transplant
  • Mild and/or moderate GI complaints directly related to MMF

Exclusion Criteria:

  • Multi-organ transplant recipients
  • Evidence of graft rejection within 14 days prior to Baseline visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619216

Locations
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7211
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Novartis Pharmaceuticals
Investigators
Principal Investigator: David Gerber, MD UNC-Chapel Hill Department of Surgery
  More Information

No publications provided

Responsible Party: David Gerber, MD/Principal Investigator, UNC Department of Surgery
ClinicalTrials.gov Identifier: NCT00619216     History of Changes
Other Study ID Numbers: 07-1203
Study First Received: February 7, 2008
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Orthotopic Liver Transplant Recipients with GI disturbance

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

ClinicalTrials.gov processed this record on May 22, 2013