NCT00089570已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 112
- 试验地点
- 37
- 主要终点
- Treatment Success
研究概览
简要总结
The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic, or acute liver disease
- •Rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to >2.5 mg/dL in less than two weeks.
- •No sustained improvement in renal function after diuretic withdrawal and plasma volume expansion
- •Proteinuria <500 mg per day
- •No evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease
排除标准
- •Ongoing shock
- •Uncontrolled bacterial infection
- •Current significant fluid losses
- •Current or recent treatment with nephrotoxic drugs (e.g. NSAIDs or aminoglycosides within 4 weeks)
- •Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose)
- •Confirmed pregnancy
- •Severe cardiovascular disease
- •Evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis)
- •Participation in other clinical studies within 30 days
研究组 & 干预措施
Terlipressin
Experimental
Terlipressin
干预措施: terlipressin (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Success
时间窗: Day 14
次要结局
- Renal function and survival(Renal funtion to Day 14 and Survival to Day 180)
研究者
研究点 (37)
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