Acute Liver FailurePhase 2/3NCT01452295
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
A Phase 2/3 study testing ELAD (Extracorporeal Liver Assist System) in people with Acute Liver Failure, run by Vital Therapies, Inc..
Trial summary
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- ELAD (Extracorporeal Liver Assist System)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Sep 2012
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects participating in the VTI-206 clinical trial.
Who cannot join
- Subjects not participating in the VTI-206 clinical trial.
About this study
Official title: Registry Protocol for Tracking the Incidence of Transplant, the Incidence and Type of Cancer, and Survival Rate of Subjects Participating in Protocol VTI-206 (NCT00973817)
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.
Read the detailed description
Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD.
The company is also collecting data related to whether a patient received a liver transplant and on survival.
- Conditions
- Acute Liver Failure
- Being tested
- ELAD (Extracorporeal Liver Assist System)
- Keywords
- liver, liver failure, acute liver failure, ELAD, alcoholic hepatitis, acute on chronic hepatitis
- Medical subject headings
- Liver Failure, Acute, Liver Failure, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELAD (Extracorporeal Liver Assist System)Drug
ELAD (Extracorporeal Liver Assist System)
| Study group | Role | What they receive |
|---|---|---|
| AOCH patients | Experimental | Patients with acute on chronic hepatitis Receives: Drug: ELAD (Extracorporeal Liver Assist System) |
| AAH patients | Experimental | Patients with acute alcoholic hepatitis Receives: Drug: ELAD (Extracorporeal Liver Assist System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gather data
See previous description
Measured: Five years post study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- 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
- NCT01452295
- Sponsor's protocol ID
- VTI-207
- Status last verified
- Dec 2013
- First submitted
- 11 Oct 2011
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Protocol for Tracking the Incidence of Transplant, the Incidence and Type of Cancer, and Survival Rate of Subjects Participating in Protocol VTI-206 (NCT00973817)
- ClinicalTrials.gov ID
- NCT01452295
- Acronym / sponsor ID
- VTI-207
- Conditions
- Acute Liver Failure
- Keywords
- liver, liver failure, acute liver failure, ELAD, alcoholic hepatitis, acute on chronic hepatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vital Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Oct 2011 (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-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.
Detailed description
Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD.
The company is also collecting data related to whether a patient received a liver transplant and on survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOCH patients | Experimental | Drug: ELAD (Extracorporeal Liver Assist System)Patients with acute on chronic hepatitis |
| AAH patients | Experimental | Drug: ELAD (Extracorporeal Liver Assist System)Patients with acute alcoholic hepatitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects participating in the VTI-206 clinical trial.
Key exclusion criteria (1 listed)
- Subjects not participating in the VTI-206 clinical trial.
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 (Extracorporeal Liver Assist System)ELAD (Extracorporeal Liver Assist System) | Drug | AAH patients, AOCH patients |
Primary outcome
Gather data
Time frame: Five years post study participation
See previous description
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 4 Dec 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.
Robert A Ashley study director
Vital Therapies, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ELAD (Extracorporeal Liver Assist System) in people with Acute 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 1 inclusion and 1 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 4 Dec 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Gather data (time frame: Five years post study participation). 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 4 Dec 2013.