跳至主要内容
临床试验/NCT00619216
NCT00619216已完成不适用

A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2008年3月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic

研究概览

简要总结

Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recipients of orthotopic liver transplant at least 8 weeks post transplant
  • Mild and/or moderate GI complaints directly related to MMF

排除标准

  • Multi-organ transplant recipients
  • Evidence of graft rejection within 14 days prior to Baseline visit

结局指标

主要结局

Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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