ClinicalTrials.gg
Not yet recruitingNCT07827235Updated Sep 22, 2026

Thyroid Disorders in Pediatric Autoimmune Hepatitis

An observational study in Thyroid Disease, Autoimmune Hepatitis and Hashimoto Thyroiditis, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
32
Ages
Up to 17 Years
Sex
All
01

Study summary

This cross-sectional study aims to determine the frequency and spectrum of thyroid disorders among children with autoimmune hepatitis attending Assiut University Children's Hospital.

Read the detailed description

Autoimmune hepatitis is frequently associated with other autoimmune disorders, particularly autoimmune thyroid diseases. Thyroid dysfunction in children may remain asymptomatic yet affect growth and development.

This observational study will include children less than 18 years diagnosed with autoimmune hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system. All participants will undergo thyroid function tests (TSH, FT3, FT4), thyroid autoantibodies (anti-TPO, anti-Tg), and thyroid ultrasonography.

02

Conditions studied

  • Thyroid Disease
  • Autoimmune Hepatitis
  • Hashimoto Thyroiditis
  • Graves Disease

Keywords

  • Autoimmune hepatitis
  • Thyroid disorders
  • Anti-TPO
  • Pediatric
  • Assiut
03

In context

Thyroid Diseases

365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.

This study's planned enrollment of 32 is below the median of 198 across 158 observational studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children less than 18 years diagnosed with autoimmune hepatitis attending the Pediatric Hepatology Unit and Outpatient Clinic at Assiut University Children's Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age less than 18 years
  • Diagnosis of hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system
  • Written from parents or legal guardians

Exclusion criteria

Exclusion Criteria:

  • - Previously diagnosed thyroid disorders before the diagnosis of hepatitis
  • Medications known to interfere with thyroid function tests (other than or therapy for AIH)
  • Chronic systemic diseases known to affect thyroid function independently of AIH
  • Other autoimmune disorders (celiac disease, diabetes, inflammatory bowel disease)
  • Refusal to participate
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
32 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Single cohort: Children with autoimmune hepatitis

    Children less than 18 years with autoimmune hepatitis who will undergo thyroid function tests, thyroid autoantibodies, and thyroid ultrasonography.

06

What researchers measure

Primary outcomes

  1. Frequency of thyroid disorders

    Number of participants with autoimmune hepatitis who have any thyroid disorder including overt or subclinical hypothyroidism, hyperthyroidism, or autoimmune thyroiditis based on thyroid function tests, autoantibodies, and ultrasonography

    Time frame: Baseline

Secondary outcomes

  1. Pattern of thyroid disorders

    Number of participants with specific thyroid disorders including Hashimoto thyroiditis, Graves disease, subclinical hypothyroidism, subclinical hyperthyroidism, and others

    Time frame: Baseline

  2. Thyroid autoantibody positivity

    Number of participants with positive anti-thyroid peroxidase and/or anti-thyroglobulin antibodies

    Time frame: Baseline

  3. Thyroid ultrasonographic abnormalities

    Proportion of children with abnormal thyroid ultrasound findings (enlargement, hypoechogenicity, nodules, or altered vascularity).

    Time frame: Baseline

  4. Serum TSH level

    Mean serum thyroid-stimulating hormone (TSH) level (µIU/mL).

    Time frame: Baseline

  5. Serum free T4 level

    Mean serum free thyroxine (FT4) level (ng/dL).

    Time frame: Baseline

  6. Serum free T3 level

    Mean serum free triiodothyronine (FT3) level (pg/mL).

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Mieli-Vergani G, Vergani D, Baumann U, Czubkowski P, Debray D, Dezsofi A, Fischler B, Gupte G, Hierro L, Indolfi G, Jahnel J, Smets F, Verkade HJ, Hadzic N. Diagnosis and Management of Pediatric Autoimmune Liver Disease: ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. 2018 Feb;66(2):345-360. doi: 10.1097/MPG.0000000000001801. PubMed 29356770 ↗
  • Ijaz MK, Sattar SA, Boone SA, Nims RW, McKinney J, Gerba CP. Dynamics of respiratory virus spread indoors suggest a holistic approach for exposure risk mitigation. Antimicrob Steward Healthc Epidemiol. 2025 Oct 29;5(1):e289. doi: 10.1017/ash.2025.10147. eCollection 2025. PubMed 41180295 ↗
  • Chen M, Gu H, Xuan G, Ma L, Tu S, Li M. Elective neck dissection versus elective neck irradiation in cT3/4N0 maxillary sinus squamous cell carcinoma: a propensity score matching analysis. World J Surg Oncol. 2024 Apr 15;22(1):95. doi: 10.1186/s12957-024-03368-8. PubMed 38622695 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 18, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Sep 25, 2027
CompletionEst.
Feb 10, 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07827235
Lead sponsor
Assiut University
Responsible party
Arwa Alaaeldin Mohamed Ahmed (Resident Physician, Pediatrics, Assiut University) — Principal investigator
First posted
Sep 18, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Sep 25, 2027 (estimated)
Completion
Feb 10, 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Arwa M Mohamed, Resident
Contact
Arwa.18313343@med.aun.edu.eg
+20 10 26065202
Amal A seliman, prof
study chair · pediatrics Department, Assiut University Hospitals
Shereen M Galal, Prof
study chair · pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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