Fulminant Hepatic FailurePhase 2ELADNCT00832728
Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)
A Phase 2 study testing ELAD® in people with Fulminant Hepatic Failure, run by Vital Therapies, Inc. at 12 sites in United States.
Trial summary
This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical therapy for FHF plus the ELAD® system, or standard medical therapy alone, with the latter… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Fulminant Hepatic Failure
- What is being tested?
- ELAD®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2009to Sep 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight ≥15 kilograms;
- Age ≥10 ≤65 years;
- Diagnosis of FHF;
- Patients must have been treated with a standard regimen of N-acetyl cysteine (NAC) involving a loading dose of 150mg/kg/hr over 1 hour followed by 12.5 mg/kg/hour x 4 hours then continuous infusion of 6.25 mg/kg for the remaining 67 hrs.
- Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements AND EITHER
- Known acetaminophen ingestion or diagnostic serum level, and at least one of the following:
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- prothrombin time (PT) >30 seconds (International Normalized Ratio (INR) >6.5, OR; b. Encephalopathy Grade II, III or IV and at least one of the following: i. Arterial pH <7.30 at ≥2 hours after initial diagnosis, OR; ii. renal failure documented by urine output less than 2 mL/kg/hr over 12 hours, OR; iii. creatinine >2.5 mg/dL; OR
- Patients with Non-Acetaminophen-Induced FHF:
- Stage II, III or IV encephalopathy, and the presence of at least two of the following five criteria: i. Non-A/Non-B hepatitis or drug (non-acetaminophen) induced FHF; ii. Serum bilirubin >17 mg/dL; iii. Patient ≥10 or <40 years old; iv. Prothrombin time >25 seconds (INR > 3.5), AND/OR; v. Jaundice to encephalopathy time ≥7 days; OR
- Liver transplantation within 10 days of the screening procedures, but meeting inclusion criteria due to primary graft non-function, and not receiving ELAD® therapy prior to the first graft
Who cannot join
- Cerebral Perfusion Pressure as measured by an intracranial pressure (ICP) monitor. (NOTE: In those cases where ICP monitor placement cannot be performed prior to study enrollment, this exclusion criterion will not apply):
- Patients > 18 yrs of age with Cerebral Perfusion Pressures (CPP) ≤40 mm Hg for one hour or longer.
- Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
- Chronic liver disease;
- 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 (e.g., variceal bleed, caput Medusae, and clinically obvious ascites);
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- Liver dysfunction due to trauma;
- Hemorrhage or irreversible brain death ( i.e. blood flow studies positive for herniation and/or pupillary reflex absent);
- Platelet count <50,000/mm3 or reducing to <80,000/mm3 over a 72 hr. period. (NOTE: Patient may be included at the physician's discretion if platelet count exceeds 50,000mm3 at time of initiation of therapy and can be managed through the administration of blood products);
- 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, not corrected by medical management (including CVVH if indicated);
- Pregnancy as determined by βhCG results;
- ≤2 weeks postpartum;
- Participation in another investigational study within 30 days of enrollment;
- Prior ELAD® therapy.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Virginia
Charlottesville, Virginia, 22908
Loyola University Medical Center
Chicago, Illinois, 60153
University of Chicago Medical Center
Chicago, Illinois, 60637
Indiana University
Indianapolis, Indiana, 46202
Scripps Green Hospital
La Jolla, California, 92037
Cedars Sinai Medical Center
Los Angeles, California, 90048
New York University Medical Center
New York, New York, 10016
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Rochester, Strong Memorial
Rochester, New York, 14642
California Pacific Medical Center
San Francisco, California, 94115
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, 71103
About this study
This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical therapy for FHF plus the ELAD® system, or standard medical therapy alone, with the latter defined as conventional therapy for FHF determined to be clinically appropriate by the treating physician.
Read the detailed description
Therapy will generally include treatment of hepatic encephalopathy using lactulose with or without oral antibiotics, antibiotics as indicated to treat infection, volume resuscitation and vasopressors as indicated to treat hypotension. In addition general medical treatment such as glucose control and renal replacement therapy will be used as necessary. Subjects with a clinical diagnosis of hepato-renal syndrome may be treated with midodrine and octreotide or terlipressin, if considered appropriate therapy.
Immediately prior to treatment initiation, subject eligibility will be confirmed. Treatment with ELAD® will continue for a minimum of 3 days and up to a maximum of 30 days, until, in the Investigator's opinion, clinical status improves relative to entry; until the subject undergoes OLT; or until the continued use of ELAD® is contraindicated, as described in Section 5.5. Subjects will be followed until discontinuation or 30 days has elapsed since study enrollment (control) or 30 days has elapsed since cessation of ELAD® therapy (ELAD® group), whichever comes first.
- Conditions
- Fulminant Hepatic Failure
- Being tested
- Standard of Care, ELAD®
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Standard hospital protocol for the treatment of acute liver failure
ELAD®Device
ELAD therapy
| Study group | Role | What they receive |
|---|---|---|
| ELAD | Active comparator | ELAD Therapy + Standard of Care Receives: Other: Standard of Care; Device: ELAD® |
| Standard of Care | Other | Hospital based standard of care for acute liver failure Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of ELAD® therapy: 1) as a bridge-to-transplant/recovery and 2) on 30-day transplant-free survival in subjects with FHF
Measured: 30 day
To assess its safety when used for a minimum of 3 days or up to a maximum of 30 days of treatment
Measured: 30 day
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)
- Study startMar 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: To focus on another clinical indication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fulminant Hepatic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert A Ashley, Study director, Vital Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832728
- Sponsor's protocol ID
- VTI-202
- Acronym
- ELAD
- Status last verified
- Jul 2012
- First submitted
- 29 Jan 2009
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)
- ClinicalTrials.gov ID
- NCT00832728
- Acronym / sponsor ID
- ELAD / VTI-202
- Conditions
- Fulminant Hepatic Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: To focus on another clinical indication.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vital Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- 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.
This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical therapy for FHF plus the ELAD® system, or standard medical therapy alone, with the latter defined as conventional therapy for FHF determined to be clinically appropriate by the treating physician.
Detailed description
Therapy will generally include treatment of hepatic encephalopathy using lactulose with or without oral antibiotics, antibiotics as indicated to treat infection, volume resuscitation and vasopressors as indicated to treat hypotension. In addition general medical treatment such as glucose control and renal replacement therapy will be used as necessary. Subjects with a clinical diagnosis of hepato-renal syndrome may be treated with midodrine and octreotide or terlipressin, if considered appropriate therapy.
Immediately prior to treatment initiation, subject eligibility will be confirmed. Treatment with ELAD® will continue for a minimum of 3 days and up to a maximum of 30 days, until, in the Investigator's opinion, clinical status improves relative to entry; until the subject undergoes OLT; or until the continued use of ELAD® is contraindicated, as described in Section 5.5. Subjects will be followed until discontinuation or 30 days has elapsed since study enrollment (control) or 30 days has elapsed since cessation of ELAD® therapy (ELAD® group), whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELAD | Active comparator | Other: Standard of Care, Device: ELAD®ELAD Therapy + Standard of Care |
| Standard of Care | Other | Other: Standard of CareHospital based standard of care for acute liver failure |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Weight ≥15 kilograms;
- Age ≥10 ≤65 years;
- Diagnosis of FHF;
- Patients must have been treated with a standard regimen of N-acetyl cysteine (NAC) involving a loading dose of 150mg/kg/hr over 1 hour followed by 12.5 mg/kg/hour x 4 hours then continuous infusion of 6.25 mg/kg for the remaining 67 hrs.
- Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements AND EITHER
Key exclusion criteria (19 listed)
- Cerebral Perfusion Pressure as measured by an intracranial pressure (ICP) monitor. (NOTE: In those cases where ICP monitor placement cannot be performed prior to study enrollment, this exclusion criterion will not apply):
- Chronic liver disease;
- 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 (e.g., variceal bleed, caput Medusae, and clinically obvious ascites);
- Liver dysfunction due to trauma;
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 |
|---|---|---|
| Standard of CareStandard hospital protocol for the treatment of acute liver failure | Other | ELAD, Standard of Care |
| ELAD®ELAD therapy | Device | ELAD |
Primary outcome
The effect of ELAD® therapy: 1) as a bridge-to-transplant/recovery and 2) on 30-day transplant-free survival in subjects with FHF
Time frame: 30 day
To assess its safety when used for a minimum of 3 days or up to a maximum of 30 days of treatment
Time frame: 30 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
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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.
Robert A Ashley study director
Vital Therapies, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELAD® in people with Fulminant Hepatic Failure, run by Vital Therapies, Inc. at 12 sites in United States.
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 10 inclusion and 19 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: withdrawn, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
The effect of ELAD® therapy: 1) as a bridge-to-transplant/recovery and 2) on 30-day transplant-free survival in subjects with FHF (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 25 Jul 2012.