NCT00771446 (ELAD) is a Phase 1/Phase 2 clinical trial of ELAD plus standard of care treatment in Acute Hepatitis, sponsored by Vital Therapies, Inc..

Who is sponsoring NCT00771446?

NCT00771446 is sponsored by Vital Therapies, Inc..

What drugs are being tested in NCT00771446?

Interventions in NCT00771446: ELAD plus standard of care treatment, Standard of care treatment.

What condition does NCT00771446 study?

NCT00771446 studies Acute Hepatitis, Chronic Hepatitis.

Is NCT00771446 still recruiting?

NCT00771446 is currently completed. Last updated 5 April 2013.

Last reviewed 2013-04-05 · How we verify

NCT00771446: ELAD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) in Patients With Acute on Chronic Hepatitis (AOCH)

Completed Phase 1/Phase 2 Last updated 5 April 2013

What this trial tests

Phase 1/Phase 2 trial testing ELAD plus standard of care treatment in Acute Hepatitis in 18 participants. Completed in 1 April 2009.

Timeline

1 October 2008

Primary endpoint
1 April 2009

1 April 2009

Quick facts

Lead sponsor	Vital Therapies, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 October 2008
Primary completion	1 April 2009
Estimated completion	1 April 2009
Sites	6 locations across United States

Drugs / interventions tested

ELAD plus standard of care treatment — full drug profile →
Standard of care treatment — full drug profile →

Conditions studied

Acute Hepatitis — all drugs for Acute Hepatitis →
Chronic Hepatitis — all drugs for Chronic Hepatitis →

Sponsor

Vital Therapies, Inc. — full company profile →

Who can join

Adults 19 to 69, any sex, with Acute Hepatitis or Chronic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To provide evidence that (1) subjects treated with ELAD have a higher 30-day transplant-free survival in subjects with AOCH than those not treated with ELAD, and (2) it is safe when used for 3 to 10 days of treatment.
Time frame: 12 months

Sponsor's own description

Evaluate on how well the ELAD system works in treating people with liver failure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00771446 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vital Therapies, Inc.
Last refreshed: 5 April 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00771446.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing