Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832273
Recruitment Status : No longer available
First Posted : January 30, 2009
Last Update Posted : September 10, 2013
Information provided by (Responsible Party):
Vital Therapies, Inc.

Brief Summary:
VTI had established other clinical protocols to study the effects of ELAD® plus standard therapy compared with standard therapy alone in patients with acute on chronic (AOCH) (VTI-201, VTI-206) and fulminant hepatic failure (FHF) (VTI-202) and acute alcoholic hepatitis (AAH). However, liver failure (LF) patients who do not qualify for other protocols may benefit from ELAD use. In order to accommodate physician requests for the use of ELAD in LF patients who do not qualify for open Protocols, without the need to resort to individual Emergency Use INDs for each case, VTI has developed a Treatment Protocol with Cost Recovery to provide for expanded access to ELAD for those with LF. This uncontrolled Treatment Protocol has been designed to provide expanded access to ELAD in subjects with LF while assuring that sufficient data are collected to adequately monitor ELAD safety when used in this setting at multiple centers in the United States.

Condition or disease Intervention/treatment
Liver Failure Device: ELAD®

Detailed Description:
ELAD® therapy is designed to provide continuous liver support to a subject with compromised liver function, allowing time for the subject's native liver to regenerate to a healthy state, or to stabilize the subject until a suitable donor organ can be found for transplantation.

Study Type : Expanded Access
Official Title: Use of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Liver Failure: Uncontrolled Treatment Protocol to Provide Expanded Access With Cost Recovery

Intervention Details:
    Device: ELAD®
    liver assist system

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Weight ≥15 kg;
  2. Age ≥10 and ≤70 years;
  3. MELD score of ≥24;
  4. Documented liver failure;
  5. Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements.

Exclusion Criteria:

  1. Cerebral Perfusion Pressure (CPP) as measured by an intracranial pressure (ICP) monitor.:

    1. Patients ≥ 18 yrs of age with Cerebral Perfusion Pressures ≤40 mm Hg for one hour or longer.
    2. Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
  2. Concomitant disease including chronic congestive heart failure, vascular disease, emphysema, AIDS, cancer, acute fatty-liver disease, hepatitis due to herpes virus, Wilson's disease, or Budd-Chiari syndrome;
  3. Portal hypertension;
  4. Liver dysfunction due to trauma;
  5. Hemorrhage or irreversible brain death;
  6. Platelet count <50,000/mm3 or reducing to <80,000/mm3 over a 72 hour period;
  7. Mean Arterial Pressures (MAP) ≤50 mm Hg for one hour or longer as measured by an indwelling arterial line, OR; patients ≤18 years old and whose MAP is ≤40 mm Hg for one hour or longer;
  8. Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer;
  9. Clinical or radiographic evidence of stroke or intracerebral bleeding;
  10. Seizures uncontrolled by medication;
  11. Acute myocardial infarction based on clinical and/or electrocardiographic evidence;
  12. Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6;
  13. Pregnancy as determined by βhCG results;
  14. ≤2 weeks postpartum;
  15. Eligible for an open ELAD clinical trial

No Contacts or Locations Provided

Responsible Party: Vital Therapies, Inc. Identifier: NCT00832273     History of Changes
Other Study ID Numbers: VTI-501
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Vital Therapies, Inc.:
Expanded access to ELAD® in patients with liver failure

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases