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HepatitisLIVERPEDNCT06761261

Acute Hepatitis in Pediatrics

An observational study of Hepatitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to investigate wich symptoms and blood test characteristics acute hepatitis manifests in pediatric age. The study will be conducted because acute hepatitis is not an easily and clearly recognized disease in children. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Hepatitis
How many people
437 participants
Where
2 sitesItaly
Study dates
16 Oct 2023to 31 Dec 2028
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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Patients aged between 0 and 17 years, arriving at the pediatric emergency room and/or admitted to the pediatric ward of the participating centers.

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites, 2 recruiting
  • Azienda USL di Bologna Ospedale Maggiore

    Bologna, 40124

    Francesca Sbravati, MD, 0512143643 ext. +39, francesca.sbravati@ausl.bologna.it

    Francesca Sbravati, MD

    Recruiting
  • IRCCS Azienda Ospedaliero - Universitaria di Bologna

    Bologna, 40138

    Arianna Dondi, MD, 0512143012 ext. 0512143012, arianna.dondi@aosp.bo.it

    Recruiting

Other trials in Italy

About this study

This study aims to investigate wich symptoms and blood test characteristics acute hepatitis manifests in pediatric age. The study will be conducted because acute hepatitis is not an easily and clearly recognized disease in children.

This study aims to better characterize this disease by describing the frequency of the different symptoms with which it can manifest and the changes it causes in blood tests. It also aims to assess the occurrence of any complications of pediatric acute hepatitis.

The study is observational, so it is limited to collecting data and analyzing the patient's clinical course without interfering with normal clinical practice.

Read the detailed description

Acute hepatitis can be caused by a wide variety of agents, infectious and noninfectious, and vary in severity, from asymptomatic and self-limiting pictures to aggressive and fulminant forms associated with acute liver failure (ALF) that may require liver transplantation. Sometimes acute hepatitis is a prelude to mechanisms of chronic inflammation, with progressive fibrosis, evolution into cirrhosis and liver failure. In cases of hepatocyte damage, the most common laboratory finding is increased transaminases, namely aspartate amino transferase (AST, less specific being present in different tissues) and alanine amino transferase (ALT, more hepatocyte specific). In addition to transaminases, the value of alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT) are useful to better characterize liver damage. An isolated transaminase elevation in an asymptomatic subject is a frequent incidental finding and usually without pathological significance, especially if the increase is less than 2 times the upper limit of normal. Some guidelines (American College of Gastroenterology) recommend confirming the transaminase alteration with a second blood draw and assessing the degree of alteration3; others (British Society of Gastroenterology) recommend targeted investigations regardless of the level of transaminase alteration and duration of hypertransaminasemia: in this case, it is considered more important to carefully consider the clinical context and make a comprehensive assessment of liver function.Acute hepatitis is not always symptomatic, and if it does become symptomatic, the most common signs and symptoms are nonspecific (nausea and vomiting, general malaise, asthenia, anorexia, abdominal pain, jaundice, palpable liver) and do not correlate clearly with the extent of liver parenchyma damage. However, in the presence of acute liver damage, early recognition of progression to ALF is critical because of the associated high mortality, and in such cases refer the patient to a transplant center. ALF is defined as acute liver damage with altered coagulation, expressed as prolongation of the prothrombin time and increased INR, with or without the appearance of signs and symptoms of encephalopathy. In pediatric age, the most frequent causes of ALF are metabolic diseases (in particular, Wilson\'s disease), viral hepatitis, toxic forms (especially from drugs), and autoimmune forms. There is a lack of recent pediatric studies in the literature investigating the mode of presentation (signs, symptoms, and laboratory changes) of acute liver injury, and highlighting how this presentation varies by age group, depending on the different etiologies at work. Such analysis will be all the more useful considering that acute hepatitis can be clinically subtle and nonspecific, and only by integrating clinic and laboratory tests can it be recognized and diagnostic investigations aimed at recognizing the specific etiology be performed. In addition, the natural history of pediatric acute hepatitis is poorly studied, particularly the possible though rare forms with fulminant course and ALF. The present study aims to describe the clinical presentation and natural history of pediatric acute liver injury from the experience of Pediatric Emergency Room (PSP) units and Pediatrics departments. This would allow a better characterization of an often nonspecific picture, combining clinical and laboratory data, and studying how they change according to age group and different underlying etiologies. In addition, it would allow assessment of the frequency of pediatric ALF in the participating centers.

Conditions
Hepatitis
Keywords
Hepatitis
Medical subject headings
Hepatitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study the clinical-laboratory presentation of pediatric acute hepatitis and how it varies according to age group and different etiologies.

    The present study aims to describe the clinical presentation and natural history of pediatric acute liver injury from the experience of Pediatric Emergency Room (PSP) units and Pediatrics departments.

    This would allow a better characterization of an often nonspecific picture, combining clinical and laboratory data, and studying how they change according to age group and different underlying etiologies.

    In addition, it would allow assessment of the frequency of pediatric ALF in the participating centers.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start16 Oct 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
437 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06761261
Sponsor's protocol ID
LIVERPED
Acronym
LIVERPED
Status last verified
Sep 2024
First submitted
1 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.

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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Arianna Dondi (0512143012, arianna.dondi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study the clinical-laboratory presentation of pediatric acute hepatitis and how it varies according to age group and different etiologies. (time frame: through study completion, an average of 1 year). 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 7 Jan 2025.

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