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Clinical Trial Summary

The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score >0.45).


Clinical Trial Description

The Lille score will be used to identify subjects with an increased risk of mortality (Lille score failures). The Lille score is a prognostic model combining six reproducible variables at Day 0 and Day 7 of steroid treatment. The Lille score used in this protocol is being used independent of steroid administration during the 7 days of evaluation. A Lille score >0.45 (Lille score failure) indicates that the subject is at substantially increased risk of 30- and 90-day mortality. Subjects with severe acute alcoholic hepatitis (sAAH) are often treated with steroids as soon as their diagnosis is confirmed. This study is to assess treatment with the ELAD System in subjects who have failed per the Lille criteria, independent of steroid administration. ELAD treatment is done continuously for up to 10 days in addition to standard of care treatment. The Control group (those randomized not to receive ELAD treatment) will also get standard of care treatment. Standard of care is defined as the usual care for diet, medications, treatment of complications that may arise, etc. for sAAH patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01829347
Study type Interventional
Source Vital Therapies, Inc.
Contact
Status Terminated
Phase Phase 3
Start date April 2014
Completion date September 2018

See also
  Status Clinical Trial Phase
Recruiting NCT06159244 - Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients N/A