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| Sponsors and Collaborators: |
Cedars-Sinai Medical Center Novartis |
| Information provided by: | Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00574197 |
Purpose
Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of myocphenolate 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.
| Condition | Intervention | Phase |
|
Gastrointestinal Symptoms Heart Transplant |
Drug: Mycophenolate Sodium |
Phase IV |
| MedlinePlus related topics: | Heart Transplantation |
| ChemIDplus related topics: | Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium Mycophenolic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-Coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients |
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | January 2009 |
| Arms | Assigned Interventions |
|
1
all subjects switched from Myocphenolate Mofetil to Mycophenolate Sodium
|
Drug: Mycophenolate Sodium
1440mg/day (720mg by mouth, twice a day)
|
This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the inclusion criteria and report symptoms of gastrointestinal side-effects while taking Cellcept will be switched to Myfortic. All 20 patients will be followed closely over a period of 6 months following enrollment. Concomitant immunosuppressive therapy will continue in all patients per standard treatment protocol.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Gallegos, RN | (310) 423-4993 | gallegosd@cshs.org |
| United States, California | |||||
| Cedars- Sinai Medical Center | Recruiting | ||||
| Los Angeles, California, United States, 90048 | |||||
| Cedars-Sinai Medical Center |
| Novartis |
| Principal Investigator: | Ernst Schwarz, MD | Cedars-Sinai Medical Center |
More Information
| Responsible Party: | Cedars-Sinai Medical Center ( Ernst Schwarz, MD ) |
| Study ID Numbers: | 9810 |
| First Received: | December 13, 2007 |
| Last Updated: | March 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00574197 |
| Health Authority: | United States: Institutional Review Board |
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