Liver FailureHASIPRONCT02041637
Unknown Cause of Acute Liver Failure
An observational study of Liver Failure and Unknown Etiology, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Unknown Etiology
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jan 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute liver failure without cause identified at admission
Who may be able to join
- Acute liver failure defined by a PT<50% or INR>1.5;
- with or without hepatic encephalopathy;
- without cause identified at admission, and non A non B hepatitis;
- age>18 year old;
- signed an informed consent.
Who cannot join
- chronic liver disease;
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Villejuif, 94800
About this study
Official title: Unknown Cause of Acute Liver Failure: Determination of Early Mortality Predictive Factors
The purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.
Read the detailed description
Methodology: Multicentric French national cohort with prospective collection of data and constitution of biobank, in patients hospitalized in a context of acute liver failure without known cause at admission. Follow-up during 3 months for each patients. The primary objective is to determine predictive factors of early mortality. This study is an observational cohort and patients will received standard care during the follow-up.
- Conditions
- Liver Failure, Unknown Etiology
- Keywords
- liver failure, etiology, liver transplantation
- Medical subject headings
- Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: At 3 months
Secondary outcomes (3)
Liver transplantation rate
Measured: At 3 months
Overall survival rate
Measured: At 3 months
post-transplant mortality rate
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completionJan 2017
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey COILLY, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisDidier Samuel, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041637
- Sponsor's protocol ID
- AOM11030
- Acronym
- HASIPRO
- Status last verified
- Apr 2017
- First submitted
- 20 Jan 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unknown Cause of Acute Liver Failure: Determination of Early Mortality Predictive Factors
- ClinicalTrials.gov ID
- NCT02041637
- Acronym / sponsor ID
- HASIPRO / AOM11030
- Conditions
- Liver Failure, Unknown Etiology
- Keywords
- liver failure, etiology, liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Jan 2014 (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 the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.
Detailed description
Methodology: Multicentric French national cohort with prospective collection of data and constitution of biobank, in patients hospitalized in a context of acute liver failure without known cause at admission. Follow-up during 3 months for each patients. The primary objective is to determine predictive factors of early mortality. This study is an observational cohort and patients will received standard care during the follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute liver failure without cause identified at admission
Key inclusion criteria (5 listed)
- Acute liver failure defined by a PT<50% or INR>1.5;
- with or without hepatic encephalopathy;
- without cause identified at admission, and non A non B hepatitis;
- age>18 year old;
- signed an informed consent.
Key exclusion criteria (2 listed)
- chronic liver disease;
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: At 3 months
3 secondary outcomes
Liver transplantation rate
Time frame: At 3 months
Overall survival rate
Time frame: At 3 months
post-transplant mortality rate
Time frame: At 3 months
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 3 May 2017.
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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.
Audrey COILLY, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Didier Samuel, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure and Unknown Etiology, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
mortality (time frame: At 3 months). 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 3 May 2017.