EUCTR2013-001884-21-DE进行中（未招募）不适用
A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD IN SUBJECTS WITH SEVERE ACUTE ALCOHOLIC HEPATITIS (sAAH) WHO HAVE FAILED STEROID THERAPY
试验速览
- 阶段
- 不适用
- 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 = 8 mg/dL;
- •3. Medical history of alcohol abuse with evidence of causal and temporal (<6weeks) relationship to the use of alcohol and the onset of symptoms;
- •4. Maddrey score of = 32;
- •5. A clinical diagnosis of severe acute alcoholic hepatitis (sAAH) defined asmeeting two or more of the following:
- •a. Hepatomegaly
- •b. AST > ALT
- •d. Leukocytosis (WBC count above lab normal at site);
- •6. Subject must have either:
- •a. a liver biopsy that, in the investigator's opinion, confirms a diagnosis of sAAH (stratum A)
- •b. in the investigator's opinion, a liver biopsy is not justified due to the risk versus the diagnosis value, and no confirmatory liver biopsy is available, in which case the clinical diagnosis is sufficient (stratum B);
- •7. Subject must have failed steroid therapy according to the Lille protocol (Lille score >0.45) after completing 7 days of steroids;
- •8. Subject must be eligible for Standard of Care treatment as defined in the protocol;
- •9. Subject or legally authorized representative must provide Informed Consent for all phases of the study (Treatment, and 5-year Follow-Up Registry);
- •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 135
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •1. Platelet count < 50,000/mm3;
- •2. International Normalization Ratio (INR) > 3.0;
- •3. MELD score > 35;
- •4. Evidence of infection unresponsive to antibiotics (e.g. increased tissue involvement relative to initial diagnosis, clinical worsening of symptom, 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;
- •5. Evidence of more than one steroid regimen during this episode of liver failure;
- •6. Hospital admission for any other episodes of liver decompensation within the past 2 months;
- •7. 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 at maximum vasopressor dose at Screening or Randomization (low doses are allowed);
- •low dose vasopressor doses are defined as:
- •Dobutamine: Low doses: 2.5 to 5.0 mcg/kg/min
- •Dopamine: Low doses: 0.5 to 2 mcg/kg/min
- •Norepinephrine: Low doses: 0.01 to 0.02 mcg/kg/min
- •Phenylephrine: Low doses: 0.05 to 1 mcg/kg/min
- •Vasopressin: Low doses: 0.01 to 0.02 U/min
- •8. Evidence of active bleeding or of major hemorrhage defined as requiring = 2 units packed red blood cells to maintain a stable hemoglobin occurring within 48 hours of Screening;
- •9. Evidence of occlusive portal vein thrombosis impairing hepatopetal flow, or evidence of bile duct obstruction;
- •10. Evidence by physical exam, history, or laboratory evaluation of significant concomitant disease with expected 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;
- •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 < 750 cc as determined by CT], unless Investigator interpretation of the clinical evidence indicates liver size of < 10 cm or volume < 750cc is not considered reduced for the individual subject;
- •12. Chronic end-stage renal disease requiring chronic hemodialysis for more than 8 weeks (not classified as hepatorenal syndrome);
- •13. Uncontrolled seizures;
- •14. Positive serologies for viral hepatitis B (HBsAg) or hepatitis C indicating acute/chronic infection or a positive viral load for either hepatitis B or C;
- •15. Pregnancy as determined by ß-human chorionic gonadotropin (HCG) results;
- •16. Participation in another investigational drug, biologic, or device study within one month of
- •enrollment, except for observational studies (the observational study setting should not affect the safety and/or efficacy of the VTI-210 clinical trial);
- •17. Currently listed or scheduled for liver transplant during the 90-day study period;
- •18. Previous liver transplant;
- •19. Previous
研究者
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