Liver FailureNCT00832273
Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery
A study testing ELAD® in people with Liver Failure, run by Vital Therapies, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Liver Failure
- What is being tested?
- ELAD®
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Liver Failure
- Being tested
- ELAD®
- Keywords
- Expanded access to ELAD® in patients with liver failure
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELAD®Device
liver assist system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Vital Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832273
- Sponsor's protocol ID
- VTI-501
- Status last verified
- Sep 2013
- First submitted
- 29 Jan 2009
- Last updated
- 10 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00832273
- Acronym / sponsor ID
- VTI-501
- Conditions
- Liver Failure
- Keywords
- Expanded access to ELAD® in patients with liver failure
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Vital Therapies, Inc.Industry (pharma, biotech, devices)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- Cerebral Perfusion Pressure (CPP) as measured by an intracranial pressure (ICP) monitor.:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELAD®liver assist system | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ELAD® in people with Liver Failure, run by Vital Therapies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.