| December 13, 2007 |
| August 20, 2009 |
| June 2006 |
| December 2009 (final data collection date for primary outcome measure) |
| Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale), GI complications and GI adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00574197 on ClinicalTrials.gov Archive Site |
| Incidence of biopsy proven acute rejection, graft loss, and death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients |
| Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients |
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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
- Gastrointestinal Symptoms
- Heart Transplantation
|
| Drug: Mycophenolate Sodium |
| Other: all subjects switched from Mycophenolate Mofetil to Mycophenolate Sodium |
| |
| |
| Recruiting |
| 20 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00574197 |
| Ernst Schwarz, MD, Cedars-Sinai Medical Center |
| 9810 |
| Cedars-Sinai Medical Center |
| Novartis Pharmaceuticals |
| Principal Investigator: |
Ernst Schwarz, MD |
Cedars-Sinai Medical Center |
|
|
| Cedars-Sinai Medical Center |
| August 2009 |
