HepatitisLIVERPEDNCT06761261
Acute Hepatitis in Pediatrics
An observational study of Hepatitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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
- 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
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.
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.
- First posted7 Jan 2025
- Study start16 Oct 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 437 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hepatitis in Pediatrics
- ClinicalTrials.gov ID
- NCT06761261
- Acronym / sponsor ID
- LIVERPED / LIVERPED
- Conditions
- Hepatitis
- Keywords
- Hepatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 437 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Jan 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Age between 0 and 17 years (extremes included).
- Access to PSP and/or hospitalized (OBI or hospitalization)
- Diagnosis of acute hepatitis
Key exclusion criteria (3 listed)
- 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).
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
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
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.
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 7 Jan 2025.
- 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.
2 sites in 1 country: see every site and its status.
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.