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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 437 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Bologna and 1 other locations) |
| Status | Recruiting |
| Started | October 16, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT06761261 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
- Study coordinator: Arianna Dondi
- Email: arianna.dondi@aosp.bo.it
- Phone: 0512143012
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ePro Diary for people with HDV (MACROLIVER)
This project will try a mobile ePro diary app to help adults with Delta hepatitis (HDV) track symptoms and share health information with their care team.
-
Larsucosterol for people with severe alcohol-associated hepatitis
This trial will test whether larsucosterol helps people with severe alcohol-associated hepatitis survive 90 days without needing a liver transplant.
-
Comparing two types of ultrasound for patients with viral hepatitis
This study is testing whether a new ultraportable ultrasound is better than the regular ultrasound for helping patients with viral hepatitis get accurate diagnoses and feel more comfortable during the process.
-
Low dead-space syringe and needle distribution for people who inject drugs in low- and middle-income countries
This program will test whether offering low dead-space syringes and needles to people who inject drugs at needle and syringe programs in several low- and middle-income countries increases acceptability and use of safer injecting equipment.
-
Evaluating HepaCure for treating acute-on-chronic liver failure in Chinese patients
This study is testing if a new liver support system called HepaCure, used with another treatment, can help Chinese patients with acute-on-chronic liver failure feel better compared to using the other treatment alone.
-
Evaluating TYNADOTE® for treating acetaminophen overdose
This study is testing if TYNADOTE® can help people who have overdosed on acetaminophen feel better and recover more effectively when given alongside standard treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.