| NCT ID | NCT06761261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Hepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 437 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 437 participants in total. It began in 2023-10-16 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06761261 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06761261 currently recruiting?
Yes, NCT06761261 is actively recruiting participants. Contact the research team at arianna.dondi@aosp.bo.it for enrollment information.
Where is the NCT06761261 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy.
Who is sponsoring the NCT06761261 clinical trial?
NCT06761261 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 437 participants.