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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 9
- 主要终点
- To evaluate renal function over time in liver transplant recipients after introduction of everolimus, measured by estimated glomerular filtration rate (eGFR by MDRD -4 formula) from baseline visit to month 12.
研究概览
简要总结
Everolimus has been approved globally across various countries for renal, hepatic and cardiac transplantation.
In India health authority (HA) has mandated to conduct phase IV study in Indian patients as a part of approval to marketing authorization of everolimus in liver transplant.
Thus the present observational study is planned to evaluate the efficacy and safety of everolimus in the routine clinical practice in liver transplantation in Indian patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
To evaluate renal function over time in liver transplant recipients after introduction of everolimus, measured by estimated glomerular filtration rate (eGFR by MDRD -4 formula) from baseline visit to month 12.
时间窗: From Day 0 till Month 12
次要结局
- To evaluate Acute Rejection treated Acute Rejection Biopsy-confirmed Acute Rejection treated Biopsy-confirmed Acute Rejection at 6 month and 12 month.(To evaluate incidence of Graft Loss and Death at 6 month and month 12.)
研究者
研究点 (9)
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