Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Associated Hyperammonemia With an Episode of Hepatic Encephalopathy (STOP-HE Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 231
- 主要终点
- Percentage of Participants in Each HE Stage
研究概览
简要总结
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
详细描述
The primary objectives of the study were to evaluate the efficacy of OCR-002 for treatment of an acute hepatic encephalopathy (HE) episode in cirrhotic patients requiring hospitalization and the safety and tolerability of OCR-002 in hospitalized cirrhotic patients with an acute episode of HE.
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
- Double (Participant, Investigator)
盲法说明
While the study was double-blind (participant and investigator blinded), the care provider and outcomes assessor were also blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
- •Elevated venous ammonia
排除标准
- •Renal failure with serum creatinine > 3 mg/dL or need for dialysis
- •Molecular Adsorbent Recirculation System utilized
- •Pregnancy or breastfeeding
研究组 & 干预措施
Ornithine phenylacetate
Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)
干预措施: ornithine phenylacetate (Drug)
Placebo
Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
干预措施: placebo intravenous infusion (Drug)
结局指标
主要结局
Percentage of Participants in Each HE Stage
时间窗: Baseline to End of Study (through 3 hours post end-of-infusion)
To support the primary endpoint of confirmed clinical response, the investigator rated participants on a 4-point staging scale, where higher scores are worse. The stages are described as: Stage 0/1 = Participant has no tremor of the hand when the wrist is extended (asterixis) and no confusion, even about where they are (disorientation) Stage 2 = Participant has tremor of the hand when the wrist is extended (asterixis) and is confused, not knowing where they are (disorientation) Stage 3 = Participant is tired, falling asleep, answers questions but is confused, and doesn't know where they are (Stupor, arousable but falls asleep, responsive to verbal stimuli, Obvious confusion, Gross disorientation) Stage 4 = Participant is unconscious (in a coma)
次要结局
未报告次要终点