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Myfortic Conversion Trial in OLT Recipients With GI Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00619216
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : June 3, 2011
Novartis Pharmaceuticals
Information provided by:
University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment
GI Disturbance Drug: Mycophenolic Acid (Myfortic)

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Study Type : Observational
Actual Enrollment : 31 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Intervention Details:
  • Drug: Mycophenolic Acid (Myfortic)
    Equimolar conversion from mycophenolate mofetil to mycophenolic acid
    Other Name: Cellcept; Myfortic

Primary Outcome Measures :
  1. Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recipients of Orthotopic Liver Transplants

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00619216

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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
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Principal Investigator: David Gerber, MD UNC-Chapel Hill Department of Surgery

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Responsible Party: David Gerber, MD/Principal Investigator, UNC Department of Surgery Identifier: NCT00619216    
Other Study ID Numbers: 07-1203
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: June 3, 2011
Last Verified: June 2011
Keywords provided by University of North Carolina, Chapel Hill:
Orthotopic Liver Transplant Recipients with GI disturbance
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action