Fulminant Hepatic FailurePhase 2NCT00030225
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
A Phase 2 study testing ELAD in people with Fulminant Hepatic Failure, run by Vital Therapies, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fulminant Hepatic Failure
- What is being tested?
- ELAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2002to Feb 2003
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
- Weight not less than 40 kilograms
- Not listed for organ transplant, but no medical contraindications for transplant
Who cannot join
- Listed for organ transplant at stud entry
- History of jaundice for greater than 28 days at screening
- Liver dysfunction due to trauma
- Concomitant serious disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory School of Medicine
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
University of Miami
Miami, Florida, 33136
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
UCSD
San Diego, California, 92103
About this study
Official title: Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure
The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.
Read the detailed description
Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.
- Conditions
- Fulminant Hepatic Failure
- Being tested
- ELAD, Standard of care (Control)
- Keywords
- Fulminant Hepatic Failure
- 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.
ELADBiological
Also called Extracorporeal Liver Assist Device
Standard of care (Control)Other
| Study group | Role | What they receive |
|---|---|---|
| ELAD | Experimental | Treatment with ELAD, extracorporeal liver assist system and standard of care Receives: Biological: ELAD |
| Standard of care (Control) | Other | Standard of care for patients with fulminant hepatic (liver) failure Receives: Other: Standard of care (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reaching 30-Day survival
30-day survival
Measured: Study Day 30
Secondary outcomes (1)
30-day transplant-free survival
Measured: Study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2002 (estimated)
- Study startJan 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J Maguire, MD, PhD, Study chair, VitaGen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030225
- Sponsor's protocol ID
- CR-202
- Status last verified
- Jul 2012
- First submitted
- 11 Feb 2002
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Millis M, Maguire P, Cronin D, Conjeevarum H, Johnson R, Conlin C, Brotherton J, O'Laughlin R, Triglia D, Piazza R: Continuous Human Liver Support As A Bridge To Transplantation. Hepatology- Vol.30, No.4 October 1999 p168A.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure
- ClinicalTrials.gov ID
- NCT00030225
- Acronym / sponsor ID
- CR-202
- Conditions
- Fulminant Hepatic Failure
- Keywords
- Fulminant Hepatic Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vital Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 12 Feb 2002 (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.
The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.
Detailed description
Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELAD | Experimental | Biological: ELADTreatment with ELAD, extracorporeal liver assist system and standard of care |
| Standard of care (Control) | Other | Other: Standard of care (Control)Standard of care for patients with fulminant hepatic (liver) failure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
- Weight not less than 40 kilograms
- Not listed for organ transplant, but no medical contraindications for transplant
Key exclusion criteria (4 listed)
- Listed for organ transplant at stud entry
- History of jaundice for greater than 28 days at screening
- Liver dysfunction due to trauma
- Concomitant serious disease
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 |
|---|---|---|
| ELADAlso: Extracorporeal Liver Assist Device | Biological | ELAD |
| Standard of care (Control) | Other | Standard of care (Control) |
Primary outcome
Number of subjects reaching 30-Day survival
Time frame: Study Day 30
30-day survival
1 secondary outcome
30-day transplant-free survival
Time frame: Study Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
- BackgroundMillis M, Maguire P, Cronin D, Conjeevarum H, Johnson R, Conlin C, Brotherton J, O'Laughlin R, Triglia D, Piazza R: Continuous Human Liver Support As A Bridge To Transplantation. Hepatology- Vol.30, No.4 October 1999 p168A.
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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.
Patrick J Maguire, MD, PhD study chair
VitaGen
7 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 7 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 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 7 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects reaching 30-Day survival (time frame: Study Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00030225, which also lists 1 linked publication.
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 26 Jul 2012.