NCT01766518Unknown4 期
Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Rate of acute rejection
研究概览
简要总结
Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients
详细描述
Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with primary liver transplantation recipients
- •Male and Female aged ≥19 and ≤65
- •Patient with ABO blood type correspond with Donor's blood type
- •Patient who agreement with written informed consent
- •Patient who Women if had childbearing potential must have a negative serum or urine pregnancy test at the screening visit and agreement with contraception
排除标准
- •Patient with secondary liver transplantation(LT) recipient or other organ transplantation recipient in past or current
- •Patient with multi-organ transplantation recipient
- •Patient with dual-graft transplantation recipient
- •Patient who used body artificial liver before LT
- •Cr level >2.0mg/dL in screening
- •WBC <2,000/mm3 or ANC <900/mm3 or PLT <30,000/mm3 in screening
- •Patient who experienced severe gastrointestinal disorder so investigator judge the man's participation impossible
- •Patient who experienced severe infection (need to treatment)
- •Patient or Donor with HIV positive
- •Patient who need to treat with immunosuppressant or chemistry therapy
- •Patient who had taken immunosuppressant within 30days before LT (except to take Corticosteroids and Tacrolimus due to protocol)
研究组 & 干预措施
MY-REPT capsule
Experimental
MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally
干预措施: Mycophenolate mofetil (Drug)
结局指标
主要结局
Rate of acute rejection
时间窗: up to 26weeks
Rate acute rejection by liver biopsy
次要结局
- Frequency, Time, Severity of acute rejection(up to 26 weeks)
- Kidney function test by e-GFR(Glomerular filtration rate)(up to 26weeks)
- Graft loss, Patient survival rate(up to 26weeks)
- Questionnaire of gastrointestinal symptom assessment(screening visit, closing visit)
- Questionnaire of gastrointestinal quality of life index(screening visit, closing visit)
研究者
研究点 (3)
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