CTRI/2018/07/014916招募中4 期
A prospective, phase IV study to evaluate the efficacy and safety of everolimus in liver transplant in Indian patients
ovartis India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age above 18 years of age.
- •Patients willing to participate in the study by providing written informed consent
- •Liver transplant recipient who will be receiving everolimus for the first time as per the prescribing information within six months post liver transplant.Patients should be receiving at least tacrolimus ± steroid at the time of baseline. Allograft function acceptable at time of screening as defined by AST, ALT and total bilirubin < 3 times ULN.
排除标准
- •Contraindication as per Prescribing information .
- •ABO incompatible transplant.
- •Use of Mycophenolic acid (MPA) after baseline visit
- •Use of other investigational drugs at screening, or within 30 days or 5 half-lives of screening, whichever is longer.
- •Patient with estimated GFR < 40 /min/1.73 m2 (MDRD -4) measured anytime within one month before baseline visit.Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant
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