EUCTR2015-004529-14-IE进行中（未招募）1 期
A Randomized, Open-label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation (AILD).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- 性别
- All
入选标准
- •Subjects must meet ALL inclusion criteria to be eligible for the study:
- •1. Age = 18;
- •2. Total bilirubin =16 mg/dL (=273.6 µmol/L);
- •3. A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon lab test or medical history or family interview with a causal relationship and temporal association (6 weeks or less) of alcohol use and hospital admission for this episode of AILD;
- •4. Maddrey score =32;
- •5. Subjects must have AILD that is severe acute alcoholic hepatitis (sAAH) diagnosed with either:
- •a. A confirmatory liver biopsy, OR
- •b. Two or more of the following:
- •i. Hepatomegaly,
- •ii. AST > ALT,
- •iii. Ascites,
- •iv. Leukocytosis (WBC count above lab normal at site);
- •Note: Subjects will be classified as either:
- •a. AILD that is sAAH with no underlying liver disease other than alcoholic liver disease, OR
- •b. AILD that is sAAH with evidence of underlying liver disease other than alcoholic liver disease which must be documented by:
- •i. Liver biopsy, AND/OR
- •ii. Laboratory findings, AND/OR
- •iii. Medical history;
- •6. Not eligible for liver transplant during this hospitalization;
- •7. Subject or legally-authorized representative must provide Informed Consent;
- •8. Subject must be eligible for Standard of Care treatment as defined in the protocol.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must NOT have any of the following exclusion criteria:
- •1. Age =50;
- •2. Platelet count <40,000/mm3;
- •3. International Normalization Ratio (INR) >2.5;
- •4. Serum Creatinine =1.3 mg/dL (=115.04 µmol/L);
- •5. MELD score =30;
- •6. AST >500 IU/L;
- •7. Evidence of infection unresponsive to antibiotics (e.g. increased tissue involvement relative to initial diagnosis, clinical worsening of symptoms, etc.) indicated by any of the following:
- •a. Presence of sepsis or septic shock; OR
- •b. Positive blood cultures (bacteremia, fungemia) within 72 hours prior to Randomization; OR
- •c. Presence of spontaneous bacterial peritonitis during the 2 days prior to Randomization; OR
- •d. Clinical and radiological signs of pneumonia;
- •8. Evidence of reduction in total bilirubin of 20% or more in the previous 72 hours. Bilirubin measurements must be taken at least 12 hours after any procedure known to artificially alter serum bilirubin (e.g., administration of packed red blood cells, plasma exchange);
- •9. Evidence of hemodynamic instability as defined by the following:
- •a. Systolic blood pressure <90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
- •b. Mean arterial pressure (MAP) <60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
- •c. Requirement for escalating doses of vasopressor support prior to Screening; OR
- •d. Subject on vasopressors, including but not limited to those listed below, at doses above the following at Screening or Randomization:
- •Dobutamine: 5.0 µg/kg/min
- •Dopamine: 2.0 µg/kg/min
- •Norepinephrine: 0.02 µg/kg/min
- •Phenylephrine: 1.0 µg/kg/min
- •Vasopressin: 0.02 U/min
- •10. Evidence of active bleeding, major hemorrhage defined as requiring =2 units packed red blood cells to maintain a stable hemoglobin occurring within 48 hours prior to Randomization, or with banding of gastroesophageal varices during the 7 days immediately preceding screening;
- •11. Clinical evidence of liver size reduction due to cirrhosis [liver size of the craniocaudal diameter (sagittal view) <10 cm when measured on the mid clavicular line (or equivalent measurement) by ultrasound, or liver volume <1200 cc as determined by CT or MRI], unless Investigator interpretation of the clinical evidence indicates liver size of <10 cm or volume <1200 cc is not considered reduced for the individual subject, and Sponsor agrees;
- •12. Occlusive portal vein thrombosis impairing hepatopetal flow, or evidence of bile duct obstruction;
- •13. Evidence by physical exam, history, or laboratory evaluation, of significant concomitant disease with a life expectancy of less than 3 months, including, but not limited to:
- •a. Severe acute or chronic cardiovascular, central nervous system, or pulmonary disease;
- •b. Cancer that has metastasized or has not yet been treated;
- •c. Severe metabolic abnormalities that have not been corrected;
- •14. Subject has chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
- •15. Subject ventilated or intubated;
- •16. Subject on hemodialysis;
- •17. Subject has liver disease related to homozygous hemachromotosis, Wilson's disease, has non alcoholic fatty liver disease, or Budd-Chiari Syndrome.
- •18. Serological evidence (including viral titers) of active viral hepatitis A, B o
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