NCT04147936已完成不适用
A 12-Week, Single-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Physiological Regulation of an Amino Acid Food Product, AXA1665, in Subjects With Mild and Moderate Hepatic Insufficiency
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 22
- 主要终点
- Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Child-Pugh score ≤9 (i.e. Child-Pugh class A or B)
- •Liver Frailty Index (LFI) of ≥3.6
- •Willing and able to engage in 30 minutes of walking/physical activity at least 3 days per week
排除标准
- •Hospitalization for any complication of cirrhosis or taking new medications intended to treat hepatic encephalopathy within 2 months prior to Screening or any hospitalization for any cause/reason within 30 days prior to Screening
- •Prior history or presence of a transjugular intrahepatic portal systemic shunt (TIPS)
- •Current or history of significant alcohol consumption
- •Other poorly controlled medical condition [e.g., renal disease with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2)
- •Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
- •Any extreme or unbalanced diet such as Ketogenic, Atkins, Paleo, Vegan, etc.
- •Unable or unwilling to adhere to contraception requirements
- •Any contraindications to a MRI scan
- •Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
结局指标
主要结局
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
时间窗: Baseline to Week 12
次要结局
- Change in Fischer's ratio [measured by ratio of branched-chain amino acids (leucine, valine, isoleucine) to aromatic amino acids (phenylalanine, tyrosine)](Baseline to Week 12)
- Change in muscle mass by MRI(Baseline to Week 12)
- Change in plasma ammonia(Baseline to Week 12)
- Change in Liver Frailty Index(Baseline to Week 12)
- Change in overall physical activity (measured by actigraphy watch)(Baseline to Week 12)
- Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES)(Baseline to Week 12)
- Change in creatinine concentration(Baseline to Week 12)
- Change in blood urea nitrogen concentration(Baseline to Week 12)
- Change in gait speed(Baseline to Week 12)
研究者
研究点 (22)
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