Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

Stopped early · Phase 3

Conditions studied: Acute Alcoholic Hepatitis

In brief

The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91. The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.

Key facts

Study ID: NCT02612428
Run by: Vital Therapies, Inc.
People needed: 151
Starts: 2016-01-01
Expected to finish: 2018-09-01
Last updated by the study team: 2019-01-25

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet ALL inclusion criteria to be eligible for the study:
Age ≥18;
Total bilirubin ≥16 mg/dL (≥273.6 µmol/L);
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;
Maddrey score ≥32;
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:
AILD that is sAAH with no underlying liver disease other than alcoholic liver disease, OR
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;
Not eligible for liver transplant during this hospitalization;
Subject or legally-authorized representative must provide Informed Consent;
Subject must be eligible for Standard of Care treatment as defined in the protocol.

You may not qualify if…

Subjects must NOT have any of the exclusion criteria to be eligible for the study:
Age ≥50;
Platelet count <40,000/mm3;
International Normalization Ratio (INR) >2.5;
Serum Creatinine ≥1.3 mg/dL (≥115.04 µmol/L);
MELD score ≥30;
AST >500 IU/L;
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:
Presence of sepsis or septic shock; OR
Positive blood cultures (bacteremia, fungemia) within 72 hours prior to Randomization; OR
Presence of spontaneous bacterial peritonitis during the 2 days prior to Randomization; OR
Clinical and radiological signs of pneumonia;
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);
Evidence of hemodynamic instability as defined by the following:
Systolic blood pressure <90 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
Mean arterial pressure (MAP) <60 mmHg with evidence of diminished perfusion unresponsive to fluid resuscitation and/or low-dose pressor support; OR
Requirement for escalating doses of vasopressor support prior to Screening; OR
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
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;
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;

Where it is running

University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Sharp Coronado Hospital — Coronado, California, United States
Stanford University Medical Center — Palo Alto, California, United States
Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States
Piedmont Atlanta Hospital — Atlanta, Georgia, United States
Emory University Hospital — Atlanta, Georgia, United States
Rush University Medical Center — Chicago, Illinois, United States
Mercy Medical Center — Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
University of Minnesota — Minneapolis, Minnesota, United States
University of Missouri Hospital — Columbia, Missouri, United States
Rutgers University Hospital — Newark, New Jersey, United States
Montefiore Medical Center — The Bronx, New York, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Drexel University — Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Houston Methodist Hospital — Houston, Texas, United States
University of Virginia Health System — Charlottesville, Virginia, United States
Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
Medizinische Universität Graz — Graz, Styria, Austria
Medizinische Universität Klinik Für Innere Medizin III — Vienna, Austria
Klinikum Landshut gemeinnuetzige GmbH — Landshut, Bavaria, Germany
Medizinische Hochschule Hannover — Hanover, Germany

Full record on ClinicalTrials.gov

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