NCT02350218Unknown2 期
Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Peak AST level within 7 days of Eglandin administration
研究概览
简要总结
The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST levels followed by Eglandin administration were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Primary living donor liver transplantation
- •Patient received modified right lobe graft
- •Aged between 19 to 65 years
- •Informed consent
排除标准
- •ABO incompatibility
- •Dual liver transplant patient from 2 donors
- •History of liver transplantation or other organ transplantation
- •Transplantation of other organ(s) at the time of liver transplantation
- •Use of artificial liver device prior to liver transplantation
- •UNOS status Ⅰor ⅡA
- •History of malignant tumor within 5 years
- •Not included in Milan liver transplant criteria for hepatocellular carcinoma
- •Patient with WBC < 2,000/mm3 or ANC < 900/mm3 or platelet < 30,000/mm3 at the time of screening
- •Patient exposed to severe systemic infection requiring treatment
- •Positive response for HIV in either donor or recipient
- •Prior administration of other investigational product within 30 days (or 5 times the half life) from date of screening
- •Women of childbearing age without effective contraception, breast feeding and pregnant women
- •Substance abuser, patient with metal disorder, and otherwise legally not eligible patient
- •Not eligible to participate at discrete of study investigator
研究组 & 干预措施
Eglandin 720㎍
Experimental
Eglandin® (Alprostadil) 720㎍
干预措施: Eglandin (Drug)
Eglandin 360㎍
Active Comparator
Eglandin® (Alprostadil) 360㎍
干预措施: Eglandin (Drug)
结局指标
主要结局
Peak AST level within 7 days of Eglandin administration
时间窗: 7 days
次要结局
- Time to total bilirubin recovery (within reference range)(day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration)
- Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration(5 days)
- Transplant liver survival rate on Day 180(Day 180)
- Incidence of hepatic artery/vein/portal thrombosis on Day 180(Day 180)
- Safety (other laboratory test, vital sign, adverse event) evaluation(All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180))
- Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline(7 days)
- Change in blood flow rate of hepatic artery/vein/portal from baseline at 7th, 14th, 60th, and 120th day from first dose of Eglandin administration(7th, 14th, 60th, and 120th day from first dose of Eglandin administration)
- Change in total bilirubin/AST/ALT from baseline at 7th, 14th, 30th, and 60th day from first dose of Eglandin administration(7th, 14th, 30th, and 60th day from first dose of Eglandin administration)
- Peak total bilirubin levels within 7, 14, 30 and 60 days from first dose of Eglandin administration(7, 14, 30 and 60 days from first dose of Eglandin administration)
- Peak ALT levels within 7 days of Eglandin administration(7 days)
研究者
Giwon Song
Professor
Asan Medical Center
研究点 (1)
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