Clinical trial Recruiting at 2 sites Observational Ages Any age to 17

Investigating symptoms and blood test characteristics of acute hepatitis in children

Official title: Acute Hepatitis in Pediatrics

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06761261 · Data updated 2026-11-12

This study is trying to learn more about the symptoms and blood test results of children with acute hepatitis to help doctors recognize and manage the condition better.

More Hepatitis B trials

Quick facts

Study typeObservational
AgesAny age to 17 Years
SexAll
Enrollment437 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations2 sites (Bologna and 1 other locations)
StatusRecruiting
StartedOctober 16, 2023
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJanuary 7, 2025
Trial IDNCT06761261 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 0 to 17 years who have been diagnosed with acute hepatitis.

Probably not a fit

Patients with mild hypertransaminasemia due to known chronic liver dysfunction or neonatal jaundice without hepatocyte involvement may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize acute hepatitis in pediatric patients by documenting the frequency of various symptoms and analyzing blood test results. It will assess the occurrence of complications associated with acute hepatitis, which can range from mild to severe forms that may lead to liver failure. The study will collect data on patients aged 0 to 17 years who have been diagnosed with acute hepatitis, without interfering with their normal clinical care. By understanding the clinical presentation and laboratory findings, the study seeks to improve recognition and management of this condition in children.

Why it matters

Potential benefit: If successful, this study could enhance the understanding and management of acute hepatitis in pediatric patients, leading to better outcomes.

How similar studies have gone: While there may be studies on hepatitis in adults, this specific focus on pediatric acute hepatitis is less explored, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age between 0 and 17 years (extremes included).
* Access to PSP and/or hospitalized (OBI or hospitalization)
* Diagnosis of acute hepatitis

Exclusion Criteria:

* Refusal of the parent/guardian to participate in the study.
* Mild hypertransaminasemia (\<5 times the upper limit of normal) in a patient with known chronic liver dysfunction (e.g. liver cirrhosis).
* Neonatal jaundice without hepatocyte involvement or signs of cholestasis (prevalence of indirect bilirubin with normal AST, ALT and GGT).

Where it's running

  • Azienda USL di Bologna Ospedale Maggiore
    Bologna, Italy
    Recruiting
  • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    Bologna, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.