NCT04816916终止2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)
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
- 12
- 试验地点
- 40
- 主要终点
- Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)
研究概览
简要总结
This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
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
- •Willing to participate in the study and provide written informed consent.
- •Male and female adults aged ≥18 years.
- •History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.
- •A PHES of ≤ -4 during Screening.
- •MELD score of ≤ 22 at Screening.
- •Support of a primary caregiver who is able and willing to give written informed consent.
排除标准
- •Hospitalization or serious medical condition.
- •Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).
- •History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.
- •Expectation of a liver transplant during the study.
- •Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.
研究组 & 干预措施
AXA1665 53.8 g per day
Experimental
AXA1665 administered orally TID
干预措施: AXA1665 (Drug)
Matching placebo
Placebo Comparator
Placebo administered orally TID
干预措施: Placebo (Drug)
结局指标
主要结局
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)
时间窗: Baseline to week 24
次要结局
- Time to and frequency of recurrent overt hepatic encephalopathy(Baseline to week 24)
- Impact on physical function assessed by Liver Frailty Index (a composite measure of hand grip strength, balance and ability to stand up from a chair)(Baseline to week 24)
- Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)(Baseline to week 24)
研究者
研究点 (40)
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