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

Primary Purpose

Liver Failure

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
ELAD®
Sponsored by
Vital Therapies, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Liver Failure focused on measuring Expanded access to ELAD® in patients with liver failure

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 29, 2009
    Last Updated
    September 9, 2013
    Sponsor
    Vital Therapies, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00832273
    Brief Title
    Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vital Therapies, Inc.

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Failure
    Keywords
    Expanded access to ELAD® in patients with liver failure

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    ELAD®
    Intervention Description
    liver assist system

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    70 Years
    Eligibility Criteria
    Inclusion Criteria: Weight ≥15 kg; Age ≥10 and ≤70 years; MELD score of ≥24; Documented liver failure; Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements. Exclusion Criteria: Cerebral Perfusion Pressure (CPP) as measured by an intracranial pressure (ICP) monitor.: Patients ≥ 18 yrs of age with Cerebral Perfusion Pressures ≤40 mm Hg for one hour or longer. Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer. 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; Portal hypertension; Liver dysfunction due to trauma; Hemorrhage or irreversible brain death; Platelet count <50,000/mm3 or reducing to <80,000/mm3 over a 72 hour period; 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; Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer; Clinical or radiographic evidence of stroke or intracerebral bleeding; Seizures uncontrolled by medication; Acute myocardial infarction based on clinical and/or electrocardiographic evidence; Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6; Pregnancy as determined by βhCG results; ≤2 weeks postpartum; Eligible for an open ELAD clinical trial

    12. IPD Sharing Statement

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

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