ClinicalTrials.gg
Enrolling by invitationNCT06893042Updated Mar 25, 2025

Clinical Study of Pediatric Acute Liver Failure

An observational study in Acute Liver Failure, sponsored by Fansen Zeng. Enrolling by invitation at 1 site in China. Open to participants aged 1 Minute to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Fansen Zeng · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
1 Minute to 18 Years
Sex
All
01

Study summary

The goal of this observational study is to understand the etiology, prognosis and influencing factors of acute liver failure in children, evaluate the predictive value of children's SOFA score, PELD score and LIU score for the short-term mortality rate of children's liver failure and the infection of children's acute liver failure; analyze the bleeding and kidney damage of children's acute liver failure, and evaluate the quality of life of children's acute liver failure.

Read the detailed description

PALF is a seriously life-threatening acute disease with a rapid onset, rapid progression and high mortality rate. Especially under the influence of multiple organ dysfunction syndrome (MODS) or other serious complications, clinical prognosis evaluation and treatment decision-making face great challenges.It aims to accurately evaluate the survival probability or liver transplantation needs of patients based on clinical data and biological indicators, and deeply reveal the impact of different factors on the prognosis of PALF from the perspective of etiology, treatment mode (such as mechanical ventilation and plasma replacement) and complications (such as MODS and its score), so as to provide a scientific basis for identifying high-risk groups, optimizing personalized treatment strategies and early diagnosis.

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Conditions studied

  • Acute Liver Failure

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03

In context

Liver Failure, Acute

96 studies on the registry are indexed under Liver Failure, Acute; 20 are open to participants now.

This study's planned enrollment of 7 is below the median of 112 across 34 observational studies indexed under Liver Failure, Acute.

Browse Liver Failure, Acute studies →

Lead sponsor

This is the only study on the registry with Fansen Zeng as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The children under the age of 18 diagnosed with acute liver failure in Guangzhou Women's and Children's Medical Center.

Eligibility criteria

Inclusion Criteria:

  • (1) The age is less than 18 years old; (2) Acute onset (≤8 weeks), no liver disease basis in the past; (3) Biochemical evidence of severe liver injury ; (4) Coagulation dysfunction that cannot be corrected by vitamin K: (PT) ≥15s or international standardized ratio (INR) ≥1.5, and accompanied by hepatic encephalopathy at the same time; or meet any of PT≥20s, INR≥2.0, may not be accompanied by hepatic encephalopathy; (5) Provide complete clinical data and treatment records. (6) Agree to participate in this study and obtain .

Exclusion Criteria:(1) Multiple organ failure caused by non-hepatic diseases; (2) Missing data or incomplete follow-up information.

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Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. With the changes of various indicators such as blood ammonia albumin lactic acid coagulation function with the implementation of treatment

    All are specific numerical measurements.

    Time frame: From enrollment to the end of treatment at 6 months

07

Study locations

1 site
  • Guangzhou Women's and Children's Medical Center
    Guangzhou, Guangdong 510000, China
08

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: 2026/09/01-2031/09/01

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Aug 2026, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2025
First posted
Mar 25, 2025
StartActual
Sep 1, 2024
Primary completionEst.
Aug 1, 2026
CompletionEst.
Aug 1, 2026
Last update
Mar 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06893042
Lead sponsor
Fansen Zeng
Responsible party
Fansen Zeng (associate chief physician, Guangzhou Women and Children's Medical Center) — Sponsor-investigator
First posted
Mar 25, 2025
Start date
Sep 1, 2024
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Mar 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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