5382W-13 A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF EL

A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD® IN SUBJECTS WITH ALCOHOL INDUCED LIVER DECOMPENSATION (AILD)

Type of Study
Liver - AILD
Short Description

The objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation. Subjects randomized to the ELAD® group will receive treatment with ELAD® for a maximum of five (5) 24 hour periods as well as standard medical therapy. Subjects randomized to the Control group will receive standard medical therapy throughout the study.

Status
OPEN
Principal Investigator
Marquis E Hart, MD
Eligibility Notes

Inclusion Criteria:

  • Age ≥ 18 years;
  • Total bilirubin ≥ 8 mg/dL;
  • A clinical diagnosis of alcohol-induced liver decompensation (AILD), based upon evidence (by lab test, medical history, or family interview) of a clinical judgment of a temporal (6 weeks or less) and causal relationship between use of alcohol and this onset of symptoms.
Contact Name
Terri Spinelli
Phone
206-215-3063
Alternate Phone
206-386-3660
Email
terri.spinelli@swedish.org
Alternate Email
julie.wallick@swedish.org