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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

February 7, 2008
June 1, 2011
March 2008
December 2009   (final data collection date for primary outcome measure)
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00619216 on ClinicalTrials.gov Archive Site
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Myfortic Conversion Trial in OLT Recipients With GI Intolerance
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

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Recipients of Orthotopic Liver Transplants

GI Disturbance
Drug: Mycophenolic Acid (Myfortic)
Equimolar conversion from mycophenolate mofetil to mycophenolic acid
Other Name: Cellcept; Myfortic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619216
07-1203
No
David Gerber, MD/Principal Investigator, UNC Department of Surgery
University of North Carolina, Chapel Hill
Novartis Pharmaceuticals
Principal Investigator: David Gerber, MD UNC-Chapel Hill Department of Surgery
University of North Carolina, Chapel Hill
June 2011

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