Acute Liver FailureNCT07556055
Etiology and Prognostic Factors in Patients With Acute Liver Failure
An observational study of Acute Liver Failure, run by Li-Ying Sun.
Trial summary
Acute liver failure (ALF) is a rare but life-threatening condition with high mortality. Despite advances in supportive care and liver transplantation, prognosis varies significantly across etiologies, particularly in patients with indeterminate causes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Liver Failure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 31 Dec 2037
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of patients diagnosed with acute liver failure who are treated at Beijing Friendship Hospital, Capital Medical University. Both adult and pediatric patients meeting established diagnostic criteria for acute liver failure will be included. The study includes two cohorts: a retrospective cohort of patients treated between November 2016 and February 2026, and a prospective cohort of newly diagnosed patients enrolled from March 2026 onward. Patients will be followed longitudinally to evaluate clinical outcomes, including survival, liver transplantation, and transplant-free survival.
Who may be able to join
- Patients meeting diagnostic criteria for acute liver failure:
- Adults: Acute onset without pre-existing liver disease, development of hepatic encephalopathy ≥ grade II within 4 weeks Pediatrics: Acute onset (<26 weeks), no chronic liver disease, coagulopathy not corrected by vitamin K: INR ≥1.5 with encephalopathy OR; INR >2 regardless of encephalopathy
- Patients (or guardians) who provide informed consent
Who cannot join
- Presence of end-stage extrahepatic disease without effective treatment
- Pregnant or breastfeeding women
- Inability or unwillingness to provide informed consent or comply with study procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Bidirectional Cohort Study on the Etiology and Prognostic Factors of Acute Liver Failure and Development of a Dynamic Prediction Model
Acute liver failure (ALF) is a rare but life-threatening condition with high mortality. Despite advances in supportive care and liver transplantation, prognosis varies significantly across etiologies, particularly in patients with indeterminate causes.
This study aims to investigate the dynamic changes of clinical and biochemical indicators, identify potential etiologies-especially in indeterminate ALF-and evaluate prognostic risk factors. A dynamic prediction model will be developed to optimize clinical decision-making, including liver transplantation timing.
Both retrospective and prospective cohorts will be included. Multi-omics analyses (including transcriptomics, proteomics, metabolomics, and metagenomic sequencing) will be performed on liver tissue and biological samples to explore disease mechanisms and etiology.
- Conditions
- Acute Liver 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.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation | Not described | |
| Spontaneous survival | Not described | |
| Death | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Transplant-Free Survival
Measured: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Liver Transplantation Rate
Measured: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3
Secondary outcomes (33)
Etiologic features identified by multi-omics analysis
Etiologic features in participants with acute liver failure will be assessed through multi-omics analyses of biospecimens, including liver tissue obtained from resected diseased liver during surgery (approximately 3 cm³) or from one ultrasound-guided liver biopsy core (approximately 2 cm in length), together with blood, urine, and stool samples. Multi-omics testing includes transcriptomic sequencing, proteomic analysis, metabolomic analysis, and metagenomic sequencing.
Measured: From enrollment to completion of biospecimen collection and etiologic multi-omics assessment, up to 7 days
Short-Term Mortality
Measured: 90 days after enrollment
Development of Prognostic Prediction Model
A prognostic model will be developed using clinical variables, laboratory parameters, and dynamic changes over time. Multivariable logistic regression and receiver operating characteristic (ROC) curve analysis will be used to evaluate model performance, including discrimination and calibration.
Measured: Up to 3 years after enrollment
Change in alanine aminotransferase (ALT) over time
Serial serum ALT measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in aspartate aminotransferase (AST) over time
Serial serum AST measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in total bilirubin over time
Serial total bilirubin measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in international normalized ratio (INR) over time
Serial INR measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in prothrombin time (PT) over time
Serial PT measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in serum creatinine over time
Serial serum creatinine measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in C-reactive protein (CRP) over time
Serial serum C-reactive protein measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in direct bilirubin over time
Serial direct bilirubin measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in prothrombin activity (PTA) over time
Serial prothrombin activity (PTA) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in blood ammonia over time
Serial blood ammonia measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in blood phosphorus over time
Serial blood phosphorus measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in white blood cell count (WBC) over time
Serial white blood cell count (WBC) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in red blood cell count (RBC) over time
Serial red blood cell count (RBC) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in hemoglobin (HGB) over time
Serial hemoglobin (HGB) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in platelet count (PLT) over time
Serial platelet count (PLT) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in D-dimer over time
Serial D-dimer measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in serum albumin over time
Serial serum albumin measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in arterial lactate over time
Serial arterial lactate measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in blood glucose over time
Serial blood glucose measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in arterial pH over time
Serial arterial pH measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD4+ T-cell count over time
Serial CD4+ T-cell count measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD8+ T-cell count over time
Serial CD8+ T-cell count measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD19+ B-cell count over time
Serial CD19+ B-cell count measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD56+ natural killer cell count over time
Serial CD56+ natural killer cell count measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD4+/CD8+ ratio over time
Serial CD4+/CD8+ ratio measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in immunoglobulin M (IgM) over time
Serial serum immunoglobulin M (IgM) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in immunoglobulin G (IgG) over time
Serial serum immunoglobulin G (IgG) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in immunoglobulin A (IgA) over time
Serial serum immunoglobulin A (IgA) measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in complement C3 over time
Serial serum complement C3 measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Change in complement C4 over time
Serial serum complement C4 measurements will be obtained every 48 hours from admission until discharge to assess dynamic changes during hospitalization.
Measured: Every 48 hours from admission to discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2037 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Li-Ying Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li-Ying Sun, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556055
- Sponsor's protocol ID
- BFHHZS20260102
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bidirectional Cohort Study on the Etiology and Prognostic Factors of Acute Liver Failure and Development of a Dynamic Prediction Model
- ClinicalTrials.gov ID
- NCT07556055
- Acronym / sponsor ID
- BFHHZS20260102
- Conditions
- Acute Liver Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Li-Ying SunUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 29 Apr 2026 (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.
Acute liver failure (ALF) is a rare but life-threatening condition with high mortality. Despite advances in supportive care and liver transplantation, prognosis varies significantly across etiologies, particularly in patients with indeterminate causes.
This study aims to investigate the dynamic changes of clinical and biochemical indicators, identify potential etiologies-especially in indeterminate ALF-and evaluate prognostic risk factors. A dynamic prediction model will be developed to optimize clinical decision-making, including liver transplantation timing.
Both retrospective and prospective cohorts will be included. Multi-omics analyses (including transcriptomics, proteomics, metabolomics, and metagenomic sequencing) will be performed on liver tissue and biological samples to explore disease mechanisms and etiology.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation | – | – |
| Spontaneous survival | – | – |
| Death | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients diagnosed with acute liver failure who are treated at Beijing Friendship Hospital, Capital Medical University. Both adult and pediatric patients meeting established diagnostic criteria for acute liver failure will be included. The study includes two cohorts: a retrospective cohort of patients treated between November 2016 and February 2026, and a prospective cohort of newly diagnosed patients enrolled from March 2026 onward. Patients will be followed longitudinally to evaluate clinical outcomes, including survival, liver transplantation, and transplant-free survival.
Key inclusion criteria (3 listed)
- Patients meeting diagnostic criteria for acute liver failure:
- Adults: Acute onset without pre-existing liver disease, development of hepatic encephalopathy ≥ grade II within 4 weeks Pediatrics: Acute onset (<26 weeks), no chronic liver disease, coagulopathy not corrected by vitamin K: INR ≥1.5 with encephalopathy OR; INR >2 regardless of encephalopathy
- Patients (or guardians) who provide informed consent
Key exclusion criteria (3 listed)
- Presence of end-stage extrahepatic disease without effective treatment
- Pregnant or breastfeeding women
- Inability or unwillingness to provide informed consent or comply with study procedures
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
Overall Survival
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Transplant-Free Survival
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)
Liver Transplantation Rate
Time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3
33 secondary outcomes
Etiologic features identified by multi-omics analysis
Time frame: From enrollment to completion of biospecimen collection and etiologic multi-omics assessment, up to 7 days
Short-Term Mortality
Time frame: 90 days after enrollment
Development of Prognostic Prediction Model
Time frame: Up to 3 years after enrollment
Change in alanine aminotransferase (ALT) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in aspartate aminotransferase (AST) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in total bilirubin over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in international normalized ratio (INR) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in prothrombin time (PT) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in serum creatinine over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in C-reactive protein (CRP) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in direct bilirubin over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in prothrombin activity (PTA) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in blood ammonia over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in blood phosphorus over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in white blood cell count (WBC) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in red blood cell count (RBC) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in hemoglobin (HGB) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in platelet count (PLT) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in D-dimer over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in serum albumin over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in arterial lactate over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in blood glucose over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in arterial pH over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD4+ T-cell count over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD8+ T-cell count over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD19+ B-cell count over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD56+ natural killer cell count over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in CD4+/CD8+ ratio over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in immunoglobulin M (IgM) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in immunoglobulin G (IgG) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in immunoglobulin A (IgA) over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in complement C3 over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Change in complement C4 over time
Time frame: Every 48 hours from admission to discharge, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure, run by Li-Ying Sun.
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 3 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: opening soon, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wan-Ting Zhang, MD (+86 13699189579, 13699189579@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to 3 years after enrollment (every 3 months during the first year, then annually until year 3)). The study lists 3 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 29 Apr 2026.