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
Sponsor study identifier
observational
31
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 7, 2008
Actual (reported)February 20, 2008
Actual (reported)March 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Actual (reported)December 2009
Actual (reported)Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic
3 months
Equimolar conversion from mycophenolate mofetil to mycophenolic acid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Recipients of Orthotopic Liver Transplants
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599-7211, United States
David Gerber, MD
UNC-Chapel Hill Department of Surgery
31 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2008
First Posted
February 20, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
June 3, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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