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Myfortic Conversion Trial in OLT Recipients With GI Intolerance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00619216
First Posted: February 20, 2008
Last Update Posted: June 3, 2011
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.
Collaborator:
Novartis Pharmaceuticals
Information provided by:
University of North Carolina, Chapel Hill
  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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: David Gerber, MD/Principal Investigator, UNC Department of Surgery
ClinicalTrials.gov Identifier: NCT00619216     History of Changes
Other Study ID Numbers: 07-1203
First Submitted: February 7, 2008
First Posted: February 20, 2008
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:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action