NCT01373606已完成1 期
An Exploratory Study of FE999908 in Patients With Hepatorenal Syndrome Type 1
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in SCr value from baseline to end of treatment
研究概览
简要总结
This is an open-label, multi-center study, investigating the efficacy and safety of terlipressin in Japanese patients with hepatorenal syndrome type 1.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed with HRS type 1 according to the diagnostic criteria of HRS and whose serum creatinine value (SCr) doubled at 2.5 mg/dL or greater within 2 weeks or whose 24h creatinine clearance (Ccr) decreased by half at less than 20 mL/min.
- •Patients should meet all the following 5 criteria:
- •[Modified International Ascites Club's Diagnostic criteria of HRS]
- •Chronic or acute liver disease with advanced hepatic failure and portal hypertension.
- •Low glomerular filtration rate (SCr >1.5 mg/dL or 24h Ccr <40 mL/min)
- •Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug
- •No sustained improvement in renal function (decrease in SCr to 1.5 mg/dL or less or increase in 24h Ccr to 40 mL/min or more) following diuretic withdrawal and expansion of plasma volume with 1,500 mL/24h of isotonic saline for 24 to 48h.
- •Protein urea <500 mg/dL, and no ultrasonographic evidence of obstructive uropathy or parenchymal renal disease
- •Age; 20 to 79 years
排除标准
- •Cr value ≥5 mg/dL
- •Child-Pugh Score ≥14
- •Fulminant hepatitis
- •Septic shock
- •Hepatocellular carcinoma that does not meet the Milan Criteria
- •Acute renal failure caused by contrast medium
- •Chronic renal failure
- •Bradycardia (heart rate <50/min)
- •Hyponatraemia (serum Na <120 mEq/L)
- •Ischemic heart diseases (angina pectoris, myocardial infarction), heart failure or clinically relevant arrhythmia
- •Poor-controlled hypertension
- •Arteriosclerosis obliterans or peripheral vascular disorder
- •Cerebrovascular disorder
- •Respiratory diseases such as chronic obstructive pulmonary disease
- •Pregnant or possibly pregnant women and patients who or whose partner desire -pregnancy during the study period
- •Patients considered by the investigator or sub-investigator as unsuitable to participate in the study
研究组 & 干预措施
Terlipressin
Experimental
干预措施: Terlipressin (Drug)
结局指标
主要结局
Change in SCr value from baseline to end of treatment
时间窗: 16 days
次要结局
- Incidence of adverse events and its severity(Up to 84 days)
- Laboratory test values(Up to 84 days)
- Vital signs(16 days)
- ECG(Day 1,4,7,10,13,16)
- The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL)(16 days)
- The percentage of patients showing 20% or more reduction in SCr value from the baseline(16 days)
- 24h Ccr, urine volume, urea nitrogen (BUN), urinary sodium excretions(16 days)
- Mean arterial blood pressure, serum Na, serum K, plasma renin activity, aldosterone, norepinephrine, antidiuretic hormone (ADH), atrial natriuresis peptide (ANP)(16 days)
- Overall survival(Up to 84 days)
- Pharmacokinetics - assessment of blood concentration(Blood PK sample collection: pre-dose, 5, 15, 30, 60, 90, 120, 150, 180, 240, and 360 minutes post-dose)
研究者
研究点 (1)
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