NCT01912404终止2 期
A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Survival
研究概览
简要总结
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.
详细描述
The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver function.
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
- 21 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 patient or patient's legally acceptable representative), and understand and willing to comply with the requirements of the study
- •Male or female patients 21 years of age or older
- •Patients with alcoholic hepatitis defined as:
- •History of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for most days in a minimum period of 6 months
- •Consumed alcohol within 6 weeks of entry into the study
- •Biochemical parameters of severe disease as evidenced by MELD score >20 but <35, or MELD score 35-40 if the SOFA score is <10
- •Willingness to utilize 2 reliable forms of contraception (for both males and females of childbearing potential) from screening to 1 month after the completion of study treatment
- •Patients with established contraindications to steroid use including but not limited to the following:
- •Active infection, including spontaneous bacterial peritonitis, based on positive blood culture, urine culture, or chest x-ray (if positive, must have been on antibiotics for at least 24 hours prior to study entry)
- •Acute pancreatitis (increased lipase > 3x ULN or radiologic evidence)
- •Positivity for hepatitis B (HBsAg+) or C virus (HCV+), and
- •Renal failure
排除标准
- •Other or concomitant cause of liver disease as a result of:
- •Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
- •Metabolic liver disease (abnormal ceruloplasmin levels)
- •Vascular liver disease
- •Drug induced liver disease Note: Concurrent viral hepatitis is not excluded.
- •Co-infection with human immunodeficiency virus (HIV)
- •Sepsis as evidenced by positive blood or urine culture, or pneumonia as confirmed by x-ray
- •History of renal transplant and/or on dialysis at time of entry into study
- •Inflammatory bowel disease
- •Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
- •Hepatocellular carcinoma (HCC) at entry into the study
- •Active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
- •Active tuberculosis on chest x-ray at study entry
- •History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
- •Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
- •Patients requiring the use of vasopressors or inotropic support
- •Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
- •Any patient that has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study Note: Investigational drug includes any drug that is used off-label.
- •If female, known pregnancy, or has a positive urine or serum pregnancy test, or lactating/breastfeeding
- •If male, if partner is known to be pregnant at time of entry into study or becomes pregnant while patient is on study drug or up to 1 month after completion of study drug
- •Appropriate candidate for corticosteroid therapy
- •Treatment for alcohol hepatitis within 1 month of study entry with use of corticosteroids for >1 week or corticosteroid use at the time of entry into the study.
研究组 & 干预措施
IDN-6556
Experimental
IDN-6556 capsules, 25 mg BID
干预措施: IDN-6556 (Drug)
Placebo
Placebo Comparator
Placebo capsules BID
干预措施: Placebo (Drug)
结局指标
主要结局
Survival
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (3)
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