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NCT00973817 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis

A Phase 2 study of Acute On Chronic Hepatitis, sponsored by Vital Therapies.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target
20
Study locations

NCT00973817: Completed Phase 2 study of Acute On Chronic Hepatitis, sponsored by Vital Therapies.

NCT00973817 is a Phase 2 study of Acute On Chronic Hepatitis that has completed, run by Vital Therapies. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00973817, a Phase 2 study of Acute On Chronic Hepatitis, has completed, sponsored by Vital Therapies.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to investigate the safety and efficacy of the use of ELAD in patients with diagnosed Acute On Chronic Hepatitis, including Acute Alcoholic Hepatitis.

Primary Outcome

This is based on death or the first observed increase of at least 5 points from Baseline MELD score (whichever occurs earlier) at least 24 hours after the ELAD® Treatment Period is ended and up to Study Day 91 (90 days following Baseline).

Conditions Studied

Interventions

  • OTHER Standard of care
  • BIOLOGICAL ELAD plus standard of care treatment

Study Locations (20)

New York

  • New York University Medical Center - New York
  • Columbia University Medical Center - New York
  • Univ. of Rochester, Strong Memorial Hospital - Rochester
  • Westchester Medical Center - Valhalla

Pennsylvania

  • Drexel University College of Medicine - Philadelphia
  • Temple University - Philadelphia
  • Albert Einstein Medical Center - Philadelphia

Other

  • Royal Derby Hospital - Derby
  • Edinburgh Royal Infirmary - Edinburgh
  • St. James University Hospital - Leeds

California

  • Cedars Sinai Medical Center - Los Angeles
  • California Pacific Medical Center - San Francisco

Texas

  • The Liver Institute at Methodist Dallas Medical Center - Dallas
  • Baylor University Medical Center - Dallas

England

  • University Hospitals Birmingham - Birmingham
  • Kings College Hospital NHS Foundation Trust - London

Illinois

  • University of Chicago Medical Center - Chicago

Indiana

  • Indiana University - Indianapolis

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2009-09
Est. Completion 2011-05
Phase Phase 2
Vital Therapies

7 total trials

What the finished NCT00973817 record still lists

NCT00973817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Acute On Chronic Hepatitis appearing as the primary indexed condition, and to 2 interventions - of which Standard of care is the first listed.

NCT00973817 names 20 study sites across 10 states, led by New York, Pennsylvania, Other.

Frequently Asked Questions

What is clinical trial NCT00973817 about?

NCT00973817 is a clinical study titled "Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis". The purpose of this study is to investigate the safety and efficacy of the use of ELAD in patients with diagnosed Acute On Chronic Hepatitis, including Acute Alcoholic Hepatitis.

What is the current status of trial NCT00973817?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2009-09. Estimated completion is 2011-05.

What conditions does trial NCT00973817 study?

This clinical trial studies the following conditions: Acute On Chronic Hepatitis.

What interventions are being tested in trial NCT00973817?

The interventions under investigation include: Standard of care (OTHER), ELAD plus standard of care treatment (BIOLOGICAL).

Who is sponsoring clinical trial NCT00973817?

This trial is sponsored by Vital Therapies, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00973817 being conducted?

This trial has 20 study locations across California, Illinois, Indiana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00973817's enrollment target sits among peer trials

62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00973817, the US trial registry maintained by the National Library of Medicine. NCT00973817 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.