Hepatitis ANCT07848321
Risk Factors and Outcomes of Hepatitis A in Children
An observational study of Hepatitis A and Acute Hepatitis, run by Assiut University.
Trial summary
This prospective observational study aims to evaluate the risk factors, clinical course, and outcomes among children with acute hepatitis A infection admitted to Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hepatitis A, Acute Hepatitis
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 25 Mar 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with confirmed acute hepatitis A infection admitted to or presenting at Assiut University Children Hospital.
Who may be able to join
- Age 1 month to 18 years
- Confirmed acute hepatitis A infection by positive Anti-HAV IgM
- Written informed consent from parents or legal guardians
Who cannot join
- - Co-infection with hepatitis B, hepatitis C, or hepatitis E
- Chronic liver diseases (autoimmune hepatitis, Wilson disease, metabolic liver diseases)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Factors, Clinical Course and Predictors of Outcome in Children With Hepatitis A Infection Admitted in Assiut University Children Hospital
This prospective observational study aims to evaluate the risk factors, clinical course, and outcomes among children with acute hepatitis A infection admitted to Assiut University Children Hospital.
Read the detailed description
Hepatitis A virus infection is a common cause of acute hepatitis in children in Egypt. While most cases recover completely, some children may develop complications such as prolonged cholestasis, acute liver failure, or hepatic encephalopathy.
This observational study will include children aged 1 month to 18 years with confirmed acute hepatitis A infection (positive Anti-HAV IgM). Patients will be followed during their hospital stay to assess clinical course and outcomes.
- Conditions
- Hepatitis A, Acute Hepatitis
- Keywords
- Hepatitis A, Assiut, Children, Acute liver failure
- Medical subject headings
- Hepatitis A, Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Children with acute hepatitis A | Children aged 1 month to 18 years with confirmed acute hepatitis A infection who will be followed during hospital stay to assess clinical course and outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with unfavorable outcome
Proportion of children who develop one or more of the following during hospital stay: acute liver failure, hepatic encephalopathy, acute kidney injury, ICU admission, prolonged hospital stay (>7 days), or death.
Measured: Baseline
Secondary outcomes (5)
Proportion of children with acute liver failure
Proportion of children who develop acute liver failure during hospital stay.
Measured: Baseline
Proportion of children with hepatic encephalopathy
Proportion of children who develop hepatic encephalopathy (any West Haven grade) during hospital stay.
Measured: Baseline
Mean duration of hospital stay
Mean number of days of hospitalization.
Measured: Baseline
Proportion of children requiring ICU admission
Proportion of children who require intensive care unit admission.
Measured: Baseline
Mortality rate
Proportion of children who die during hospital stay.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Ashraf Fouad, Assiut University
- Investigators
- Ahlam B Ali, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848321
- Sponsor's protocol ID
- HAV-Children-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Clinical Course and Predictors of Outcome in Children With Hepatitis A Infection Admitted in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07848321
- Acronym / sponsor ID
- HAV-Children-Assiut-2026
- Conditions
- Hepatitis A, Acute Hepatitis
- Keywords
- Hepatitis A, Assiut, Children, Acute liver failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 30 Sep 2026 (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 prospective observational study aims to evaluate the risk factors, clinical course, and outcomes among children with acute hepatitis A infection admitted to Assiut University Children Hospital.
Detailed description
Hepatitis A virus infection is a common cause of acute hepatitis in children in Egypt. While most cases recover completely, some children may develop complications such as prolonged cholestasis, acute liver failure, or hepatic encephalopathy.
This observational study will include children aged 1 month to 18 years with confirmed acute hepatitis A infection (positive Anti-HAV IgM). Patients will be followed during their hospital stay to assess clinical course and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Children with acute hepatitis A | – | –Children aged 1 month to 18 years with confirmed acute hepatitis A infection who will be followed during hospital stay to assess clinical course and outcomes. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with confirmed acute hepatitis A infection admitted to or presenting at Assiut University Children Hospital.
Key inclusion criteria (3 listed)
- Age 1 month to 18 years
- Confirmed acute hepatitis A infection by positive Anti-HAV IgM
- Written informed consent from parents or legal guardians
Key exclusion criteria (2 listed)
- - Co-infection with hepatitis B, hepatitis C, or hepatitis E
- Chronic liver diseases (autoimmune hepatitis, Wilson disease, metabolic liver diseases)
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
Proportion of children with unfavorable outcome
Time frame: Baseline
Proportion of children who develop one or more of the following during hospital stay: acute liver failure, hepatic encephalopathy, acute kidney injury, ICU admission, prolonged hospital stay (>7 days), or death.
5 secondary outcomes
Proportion of children with acute liver failure
Time frame: Baseline
Proportion of children with hepatic encephalopathy
Time frame: Baseline
Mean duration of hospital stay
Time frame: Baseline
Proportion of children requiring ICU admission
Time frame: Baseline
Mortality rate
Time frame: Baseline
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 30 Sep 2026.
- 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.
Ahlam B Ali, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis A and Acute Hepatitis, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Nada A Fouad, Resident (+20 11 18762071, Nada.17289945@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with unfavorable outcome (time frame: Baseline). 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 30 Sep 2026.