NCT01937130终止2 期
A Placebo-Controlled, Multicenter, Double-Blind, Randomized, Pharmacokinetic and Pharmacodynamic Trial of IDN-6556 in Subjects With Acute-on-Chronic Liver Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 26
- 主要终点
- Area Under the Curve (AUC)
研究概览
简要总结
The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
- •Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
- •Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
- •Subjects with an acute deterioration of liver function
- •Subjects who meet one of the following criteria:
- •Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
- •Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of > 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
- •Subjects with two organ failures
- •If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
- •Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug
排除标准
- •Known infection with HIV
- •Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
- •Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
- •Subjects with clinical evidence of disseminated intravascular coagulation
- •Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
- •Subjects who are hypotensive (defined as mean arterial pressure <70 mmHg) or require the use of inotropic support
- •Subjects with evidence of significant and/or uncontrolled bleeding
- •Subjects requiring mechanical ventilation
- •Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
- •Subjects previously exposed to IDN-6556
- •History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)
研究组 & 干预措施
IDN-6556 5 mg
Experimental
Dosed twice daily
干预措施: IDN-6556 (Drug)
IDN-6556 25 mg
Experimental
Dosed twice daily
干预措施: IDN-6556 (Drug)
IDN-6556 50 mg
Experimental
Dosed twice daily
干预措施: IDN-6556 (Drug)
Placebo
Placebo Comparator
Dosed twice daily
干预措施: Placebo (Other)
结局指标
主要结局
Area Under the Curve (AUC)
时间窗: 28 days
Primary endpoints for AUC_0-8, AUC_0 last, AUC_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.
Tmax & t1/2 Parameters
时间窗: 28 Days
Primary endpoints for tmax \& t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.
Cmax
时间窗: 28 Days
Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.
次要结局
- Levels of CK18/M30(Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28)
- Levels of CK18/M65(Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28)
- Levels of Caspase 3/7 RLU(Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28)
研究者
研究点 (26)
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