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OpenTrials
Completed

NCT Number: NCT00030225

Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure

The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.

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Key information

Conditions

Fulminant Hepatic Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCSD, San Diego, California, United States

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About this study

Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
  • Weight not less than 40 kilograms
  • Not listed for organ transplant, but no medical contraindications for transplant

Exclusion criteria

  • Listed for organ transplant at stud entry
  • History of jaundice for greater than 28 days at screening
  • Liver dysfunction due to trauma
  • Concomitant serious disease

Treatment and study plan

ELAD

Biological

Other names: Extracorporeal Liver Assist Device

Standard of care (Control)

Other

Primary outcomes

  1. Number of subjects reaching 30-Day survival

    Time frame: Study Day 30

    30-day survival

Secondary outcomes

  1. 30-day transplant-free survival

    Time frame: Study Day 30

Sponsors and collaborators

Lead sponsor

Vital Therapies, Inc.

Industry

Registry information

Official study title

Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Feb 12, 2002
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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