Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Completed · Phase 4
Conditions studied: Gastrointestinal Symptoms, Heart Transplantation
In brief
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.
Key facts
- Study ID
- NCT00574197
- Run by
- Cedars-Sinai Medical Center
- People needed
- 11
- Starts
- 2006-06-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2020-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery.
- Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy.
- Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate.
- Patients who are able to give written informed consent.
You may not qualify if…
- Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia (hemoglobin < 6g/dl) at the time of potential enrollment.
- Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
- Known sensitivity to the study drug or class of the study drug.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Use of any other investigational agent in the last 30 days.
Where it is running
- Cedars- Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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