NCT06942962

Brief Summary

Hepatitis A Virus (HAV) is a public health concern in Egypt, especially among children. Historically highly endemic, recent studies suggest a changing epidemiology. While improved socioeconomic conditions have reduced its spread, HAV remains prevalent, with over 50% of Egyptians exposed by age 15. Infection is often asymptomatic or mild in children but can be more severe with age. Prevention relies on improved sanitation and hygiene, with vaccin and recov

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Oct 2025Nov 2026

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 17, 2025

Last Update Submit

April 17, 2025

Conditions

Hepatitis AHepatitis A Virus

Keywords

Immunity with hepatitis A in childrenLymphocyte subset function in hepatitis A

Outcome Measures

Primary Outcomes (1)

  • Correlation between lymphocyte subset levels and development of hepatic encephalopathy or fulminant hepatic failure

    One year

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 1-15 years

You may qualify if:

  • Children aged 1-15 years
  • Confirmed diagnosis of acute hepatitis A infection (positive anti-HAV IgM)
  • Admitted to the hospital for management of acute hepatitis A
  • Parental/guardian consent and child assent (where appropriate) obtained

You may not qualify if:

  • Known pre-existing liver disease or chronic hepatitis
  • Immunodeficiency disorders or current immunosuppressive therapy
  • Coinfection with other hepatotropic viruses (HBV, HCV, HEV)
  • Severe malnutrition
  • Recent blood transfusion (within 3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Yigit M, Kalayci F. Vaccination status and hepatitis A immunity in children: insights from a large-scale study in Turkey. BMC Infect Dis. 2025 Jan 14;25(1):61. doi: 10.1186/s12879-025-10458-9.

    PMID: 39810097BACKGROUND

  • Malik H, Malik H, Uderani M, Berhanu M, Soto CJ, Saleem F. Fulminant Hepatitis A and E Co-infection Leading to Acute Liver Failure: A Case Report. Cureus. 2023 Apr 25;15(4):e38101. doi: 10.7759/cureus.38101. eCollection 2023 Apr.

    PMID: 37252544BACKGROUND

  • Gabrielli F, Alberti F, Russo C, Cursaro C, Seferi H, Margotti M, Andreone P. Treatment Options for Hepatitis A and E: A Non-Systematic Review. Viruses. 2023 Apr 28;15(5):1080. doi: 10.3390/v15051080.

    PMID: 37243166BACKGROUND

  • Fouad HM, Reyad EM, El-Din AG. Acute hepatitis A is the chief etiology of acute hepatitis in Egyptian children: a single-center study. Eur J Clin Microbiol Infect Dis. 2018 Oct;37(10):1941-1947. doi: 10.1007/s10096-018-3329-0. Epub 2018 Jul 20.

    PMID: 30030693BACKGROUND

  • El-Mokhtar MA, Elkhawaga AA, Ahmed MSH, El-Sabaa EMW, Mosa AA, Abdelmohsen AS, Moussa AM, Salama EH, Aboulfotuh S, Ashmawy AM, Seddik AI, Sayed IM, Ramadan HK. High Incidence of Acute Liver Failure among Patients in Egypt Coinfected with Hepatitis A and Hepatitis E Viruses. Microorganisms. 2023 Nov 30;11(12):2898. doi: 10.3390/microorganisms11122898.

    PMID: 38138042BACKGROUND

  • Elbahrawy A, Ibrahim MK, Eliwa A, Alboraie M, Madian A, Aly HH. Current situation of viral hepatitis in Egypt. Microbiol Immunol. 2021 Sep;65(9):352-372. doi: 10.1111/1348-0421.12916. Epub 2021 Aug 21.

    PMID: 33990999BACKGROUND

  • Doss W, Hermez J, Atta H, Jabbour J. Towards a hepatitis-free Egypt: is this achievable? (Editorial). East Mediterr Health J. 2018 Sep 6;24(7):609-610. doi: 10.26719/2018.24.7.609.

    PMID: 30370918BACKGROUND

  • Abosheaishaa H, Abdelghany A, Abdelhalim O, Mohamed I, Morsi S, Youssef M, Salem A, Bahbah AA, Shady A, Naguib MS, Nassar M, El-Kassas M. The Egyptian journey from having the highest prevalence of hepatitis C virus to being the first to achieve "gold tier" in conquering the disease. Proc (Bayl Univ Med Cent). 2024 Jul 22;37(5):877-883. doi: 10.1080/08998280.2024.2379185. eCollection 2024.

    PMID: 39165801BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis AHepatitis

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 24, 2025

Record last verified: 2025-04