EUCTR2012-004245-33-GB进行中（未招募）1 期
A Placebo-Controlled, Multicenter, Double-Blind, Randomized, Pharmacokinetic and Pharmacodynamic Trial of IDN-6556 in Subjects with Acute-on-Chronic Liver Failure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
- •2. Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
- •3. Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
- •Note: A variceal hemorrhage requiring hospitalization within 4 weeks of screening is acceptable if it did not result in further complications.
- •4. Subjects with an acute deterioration of liver function
- •Note: Acute deterioration is defined as a decompensating event or illness (including but not limited to alcohol use, GI hemorrhage, etc.) of = 6 weeks’ duration on a background of chronic liver disease.
- •5. Subjects who meet one of the following criteria:
- •a) Subjects with renal failure (defined as creatinine = 2.0 to = 3.4 mg/dL)
- •b) Subjects with other single organ failure with
- •I. Renal impairment (defined as an increase in creatinine of > 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or
- •ii. Hepatic encephalopathy grade I or II
- •c) Subjects with two organ failures
- •Note: If hospitalized, assessments for organ failure can be made at hospital admission (or after the subject has been treated for any precipitating event). Organ failure is defined as follows:
- •Liver: bilirubin = 12.0 mg/dL
- •Kidney: creatinine = 2.0 to = 3.4 mg/dL
- •Cerebral: hepatic encephalopathy grade III or IV
- •Coagulation: INR = 1.7
- •Lung and Circulatory failures are not defined due to the likely need for mechanical ventilation and inotropic support, respectively (see exclusion criteria).
- •6. If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
- •Note: Dose and duration of steroid therapy prior to determining responsiveness is to be defined by the treating physician.
- •7. Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Known infection with HIV
- •2. Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
- •3. Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
- •4. Subjects with clinical evidence of disseminated intravascular coagulation
- •5. Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
- •6. Subjects who are hypotensive (defined as mean arterial pressure <70 mmHg) or require the use of inotropic support
- •Note: Inotropic use, including terlipressin, is allowed at study entry if this is used for the treatment of hepatorenal syndrome and not for maintenance of blood pressure.
- •7. Subjects with evidence of significant and/or uncontrolled bleeding
- •Note: Refer to Baveno V definitions and criteria.
- •8. Subjects requiring mechanical ventilation
- •9. Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
- •10. Subjects previously exposed to IDN-6556
- •11. History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)
- •12. If female: known pregnancy, or has a positive urine or serum pregnancy test, or is lactating/breastfeeding
研究者
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