NCT05693714

Brief Summary

Adenoviruses have been linked to severe hepatitis in children. They are non-enveloped, icosahedral viruses of medium size (90-100 nm) (5). Adenoviruses usually infect the respiratory tract, eyes, urinary tract, intestines, and central nervous system (6). These diseases are

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 23, 2023

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

January 12, 2023

Last Update Submit

January 20, 2023

Conditions

Observational

Outcome Measures

Primary Outcomes (2)

  • Adenovirus infection

    Prevalence of adenovirus infection in children with autoimmune hepatitis

    2024

  • Adenovirus infection

    Prevalence of adenovirus infection in children with autoimmune hepatitis

    2025

Study Arms (1)

1

One group who have adenovirus infection

Diagnostic Test: Pcr

Interventions

PcrDIAGNOSTIC_TEST

Polymerase chain reaction

Also known as: Pcr(polymerase chain reaction)
1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cross sectional study

You may qualify if:

  • \- All children who are presented with symptoms suggestive of acute hepatitis like clinical jaundice, in the form of yellowish discoloration on sclera, fever, abdominal pain, diarrhea and raised liver enzymes between age group 2 years and 16 years.

You may not qualify if:

  • All patients under 2 years old and above 16 years.
  • History of drug intake which may affect liver functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Rana Refaat

CONTACT

0101684674914223863@med.aun.edu.eg

Rana Refaat

CONTACT

01094494643ranaarefat@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut lecturer

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

January 20, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

January 23, 2023

Record last verified: 2022-12