Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- GI Tolerability as Measured by GSRS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Enteric-coated Mycophenolate Sodium (Myfortic)
1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
干预措施: Mycophenolate Sodium (Drug)
结局指标
主要结局
GI Tolerability as Measured by GSRS
时间窗: Baseline and 6 months
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.
次要结局
- Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.(6 months)
研究者
Lawrence Czer
MD
Cedars-Sinai Medical Center