NCT04620148Unknown2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Proof-of-Concept, Phase 2a Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-242 in Subjects With Acute Alcoholic Hepatitis Causing Decompensation of Alcohol-related Cirrhosis and Acute-on-Chronic Liver Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- Change in CLIF-C ACLF score from baseline to Day 8
研究概览
简要总结
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of alcohol-related cirrhosis due to alcoholic hepatitis resulting in acute-on-chronic liver failure.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of alcohol-related cirrhosis who continue to drink heavily
- •History of an acute decompensating event with a clinical and/or liver biopsy diagnosis of alcoholic hepatitis
- •Grade 1 or 2 ACLF using the CLIF-C OF score; OR bilirubin criteria OR criteria of acute kidney injury Stage 1b or 2 after initial supportive treatment with fluids, albumin, or terlipressin; AND CLIF-C ACLF score is >35 and <64
- •History of alcohol-related cirrhosis based on clinical, radiological, and/or histological evidence
排除标准
- •Received certain previous therapies (any investigational drug within 30 days of randomization, corticosteroids for alcohol-induced liver failure within 4 weeks of randomization, or received TAK-242 in any previous study)
- •History of liver cirrhosis from other chronic diseases; liver failure from other causes
- •History of liver transplantation, post-operative decompensation after partial hepatectomy, acute or subacute liver failure without underlying cirrhosis
- •Any untreated infections including gram-positive infections, or active or latent atuberculosis, sepsis or septic shock, or coinfection with hepatitis B virus, hepatitis C virus, hepatitis E virus, or HIV
- •Chronic or pre-existing kidney failure, uncontrolled medical disorder that might confound study results or compromise subject safety, oxygen saturation <90%, or requires mechanical ventilation.
- •Uncorrected anemia, methemoglobinemia, disseminated intravascular coagulation, significant or uncontrolled bleeding, atypical laboratory screening tests.
- •Uncontrolled seizures, Grade 3 or 4 hepatic encephalopathy, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency.
- •Active extrahepatic malignancy or survival prognosis of <6 months.
研究组 & 干预措施
TAK-242
Experimental
Patients will be administered TAK-242 as a continuous IV infusion with standard care starting with a loading dose of 0.9 mg/kg administered over 30 minutes, followed by a continuous, constant rate infusion of 1.8 mg/kg/day for 7 days
干预措施: TAK-242 (Drug)
Placebo
Placebo Comparator
Patients will be administered placebo as a continuous IV infusion with standard care starting with a loading dose of 0.9 mg/kg administered over 30 minutes, followed by a continuous, constant rate infusion of 1.8 mg/kg/day for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in CLIF-C ACLF score from baseline to Day 8
时间窗: Baseline to Day 8
次要结局
- Percentage of subjects who experience at least 1 markedly abnormal treatment-emergent AE or SAE(To Day 28)
- Percentage of subjects who experience at least 1 treatment-emergent clinical laboratory test result or abnormal ECG that meets the Sponsor's markedly abnormal criteria(To Day 28)
- Percentage of subjects who discontinue study drug due to an AE(To Day 28)
- Change in naturally log-transformed key biomarkers(Baseline to day 8)
- Survival at Day 28 after initiation of TAK-242 therapy versus placebo(Baseline to Day 28)
研究者
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