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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Vital Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT00832273
First received: January 29, 2009
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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 Intervention
Liver Failure
Device: ELAD®

Study Type: Expanded Access     What is 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

Further study details as provided by Vital Therapies, Inc.:

Intervention Details:
    Device: ELAD®
    liver assist system
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.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vital Therapies, Inc.
ClinicalTrials.gov Identifier: NCT00832273     History of Changes
Other Study ID Numbers: VTI-501
Study First Received: January 29, 2009
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014