NCT00973817 (SILVER) is a Phase 2/Phase 3 clinical trial of ELAD plus standard of care treatment in Acute On Chronic Hepatitis, sponsored by Vital Therapies, Inc..

Who is sponsoring NCT00973817?

NCT00973817 is sponsored by Vital Therapies, Inc..

What drugs are being tested in NCT00973817?

Interventions in NCT00973817: ELAD plus standard of care treatment, Standard of care.

What condition does NCT00973817 study?

NCT00973817 studies Acute On Chronic Hepatitis.

Is NCT00973817 still recruiting?

NCT00973817 is currently completed. Last updated 1 April 2013.

Last reviewed 2013-04-01 · How we verify

NCT00973817: SILVER

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

Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Subjects With Acute On Chronic Hepatitis (AOCH)

Completed Phase 2/Phase 3 Last updated 1 April 2013

What this trial tests

Phase 2/Phase 3 trial testing ELAD plus standard of care treatment in Acute On Chronic Hepatitis in 62 participants. Completed in 1 May 2011.

Timeline

1 September 2009

Primary endpoint
1 April 2011

1 May 2011

Quick facts

Lead sponsor	Vital Therapies, Inc.
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	1 September 2009
Primary completion	1 April 2011
Estimated completion	1 May 2011
Sites	21 locations across United States, United Kingdom

Drugs / interventions tested

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

Conditions studied

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

Sponsor

Vital Therapies, Inc. — full company profile →

Who can join

Adults 18 to 67, any sex, with Acute On 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.

Time to progression at which a 5-point or greater Model for End stage Liver Disease (MELD) score is recorded relative to baseline
Time frame: From Baseline up to Study Day 91
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).

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Selecting Cells for Bioartificial Liver Devices and the Importance of a 3D Culture Environment: A Functional Comparison between the HepaRG and C3A Cell Lines.
van Wenum M, Adam AA, Hakvoort TB, Hendriks EJ, et al · · 2016 · cited 29× · PMID 27489500 · DOI 10.7150/ijbs.15165
New treatment options for alcoholic hepatitis.
Shasthry SM, Sarin SK. · · 2016 · cited 15× · PMID 27099434 · DOI 10.3748/wjg.v22.i15.3892

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 NCT00973817 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 1 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/NCT00973817.

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