Sponsor study identifier
interventional
11
1 country
1
Study Start
June 2006
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)Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.
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.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 13, 2007
Actual (reported)December 17, 2007
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)July 8, 2020
Actual (reported)GI Tolerability as Measured by GSRS
Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale) GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort.
Baseline and 6 months
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.
6 months
1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
1440mg/day (720mg by mouth, twice a day)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cedars- Sinai Medical Center
Los Angeles, California, 90048, United States
This is a small sample size study and 3 participants did not finish the 6 month visit
Ernst Schwarz, MD
Cedars-Sinai Medical Center
11 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2007
First Posted
December 17, 2007
Study Start
June 2006
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
July 30, 2020
Results First Posted
July 8, 2020
Record last verified: 2020-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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