Liver Failure, Acute on ChronicNCT03281265
A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China
An observational study of Liver Failure, Acute on Chronic and Liver Injury, run by Nanfang Hospital, Southern Medical University.
Trial summary
The definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well established by EASL CANONIC study. However, patients with high risk to develop ACLF has not been determined, yet. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Failure, Acute on Chronic, Liver Injury
- What is being tested?
- standard treatment
- How many people
- 1,178 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 28 Feb 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with HBV-related compensated liver disease and acute liver injury or decompensation.
Who may be able to join
- Chronic hepatitis B virus infection;
- Any of the followings: Alanine aminotransferase (ALT)≥3 upper limit of laboratory reference (ULN); Aspartate aminotransferase (AST)≥3 ULN; Serum bilirubin≥2 ULN; Acute decompensation (ascites, hepatic encephalopathy, variceal hemorrhage and/or bacterial infections)
Who cannot join
- Previous decompensation;
- those who had hepatocellular carcinoma or other types of malignancies;
- those who combined with severe chronic extra-hepatic disease;
- pregnant;
- received liver transplantation or kidney transplantation before or after admission;
- readmission;
- death within 24 hours.
About this study
The definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well established by EASL CANONIC study. However, patients with high risk to develop ACLF has not been determined, yet. The aim of current study is to establish a preliminary pre-ACLF definition, and to demonstrate the corresponding risk factors.
- Conditions
- Liver Failure, Acute on Chronic, Liver Injury
- Being tested
- standard treatment
- Keywords
- pre-acute-on-chronic liver failure, hepatitis B
- Medical subject headings
- Acute-On-Chronic Liver Failure, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentOther
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day ACLF progression
progressed to EASL defined ACLF
Measured: 28-day
28-day mortality
death within 28-day
Measured: 28-day
Secondary outcomes (1)
90-day mortality
death within 90-day
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jan 2012
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Failure, Acute on ChronicStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Retrospective
- Enrolment
- 1,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281265
- Sponsor's protocol ID
- 002
- Status last verified
- Jul 2017
- First submitted
- 11 Sep 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China
- ClinicalTrials.gov ID
- NCT03281265
- Acronym / sponsor ID
- 002
- Conditions
- Liver Failure, Acute on Chronic, Liver Injury
- Keywords
- pre-acute-on-chronic liver failure, hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,178 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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 definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well established by EASL CANONIC study. However, patients with high risk to develop ACLF has not been determined, yet. The aim of current study is to establish a preliminary pre-ACLF definition, and to demonstrate the corresponding risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with HBV-related compensated liver disease and acute liver injury or decompensation.
Key inclusion criteria (2 listed)
- Chronic hepatitis B virus infection;
- Any of the followings: Alanine aminotransferase (ALT)≥3 upper limit of laboratory reference (ULN); Aspartate aminotransferase (AST)≥3 ULN; Serum bilirubin≥2 ULN; Acute decompensation (ascites, hepatic encephalopathy, variceal hemorrhage and/or bacterial infections)
Key exclusion criteria (7 listed)
- Previous decompensation;
- those who had hepatocellular carcinoma or other types of malignancies;
- those who combined with severe chronic extra-hepatic disease;
- pregnant;
- received liver transplantation or kidney transplantation before or after admission;
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 treatment | Other | – |
Primary outcome
28-day ACLF progression
Time frame: 28-day
progressed to EASL defined ACLF
28-day mortality
Time frame: 28-day
death within 28-day
1 secondary outcome
90-day mortality
Time frame: 90-day
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 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Liver Failure, Acute on Chronic and Liver Injury, run by Nanfang Hospital, Southern Medical University.
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 2 inclusion and 7 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 23 Jan 2018. 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?
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?
28-day ACLF progression (time frame: 28-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 23 Jan 2018.