NCT04563026已完成2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 307
- 试验地点
- 68
- 主要终点
- Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).
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
- •Able to provide written informed consent (either from subject or subject's legally acceptable representative).
- •Onset of jaundice within prior 8 weeks.
- •Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice.
- •The determination of AH may be based on typical serum chemistry (as determined by local laboratory) or liver biopsy at any time during the current episode of AH:
- •Serum total bilirubin > 3.0 mg/dL
- •50 < AST < 400 IU/L
- •ALT < 400 IU/L
- •AST/ALT > 1.5
- •Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
- •Model for End-stage Liver Disease (MELD) score: 21-
- •Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the Investigator's discretion. Biopsy, if used as a diagnostic criterion, must have occurred during the current episode.
- •Male or female subjects 18 years of age or older.
- •Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
- •Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.
排除标准
- •Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
- •Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
- •Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
- •Serum creatinine >2.5 mg/dL.
- •Subjects undergoing continuous veno-venous hemodialysis (CVVH).
- •Uncontrolled gastrointestinal bleeding.
- •A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
- •Liver biopsy (if carried out) with findings not compatible with AH.
- •Stage ≥3 hepatic encephalopathy by West Haven criteria.
- •Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
- •Other concomitant cause(s) of liver disease.
- •Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
- •Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications.
- •Existing or intended pregnancy or breast feeding.
- •Participation in another interventional clinical trial within 30 days of Screening.
- •History of organ transplantation, other than a corneal transplant.
- •Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.
研究组 & 干预措施
DUR-928 (larsucosterol, 30 mg)
Experimental
干预措施: DUR-928 30 mg (Drug)
DUR-928 (larsucosterol, 90 mg)
Experimental
干预措施: DUR-928 90 mg (Drug)
(Placebo) Sterile Water for Injection
Placebo Comparator
干预措施: Placebo+ Standard of Care (SOC) (Drug)
结局指标
主要结局
Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
时间窗: Day 90
次要结局
- Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.(Day 90)
- Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.(Day 28)
- Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.(Day 28)
研究者
研究点 (68)
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