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Recruiting Observational

A Clinical Study of Hyperthyroidism in Children

NCT06570967 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2023-07-18
Last updated
2024-08-27

Condition(s) studied

Hyperthyroidism

Investigational drug(s) / intervention(s)

Methimazole(MMI) →

Methimazole(MMI): The initial dose of methimazole was 0.2-0.8 mg/(kg▪d). This dose was subsequently reduced by 25% to 50% and adjusted to maintain euthyroidism, based on the results of serum thyroid hormone testing during follow-up.

Study summary

This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.

Eligibility

Sex
ALL
Min age
29 Days
Max age
14 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≤14 years old 2. Initial diagnosis of hyperthyroidism Exclusion Criteria: 1. Hyperthyroidism had been treated with medication in other hospitals, 2. History of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation, 3. Patients with incomplete clinical data

Primary outcome measure(s)

  • Remission of hyperthyroidism in children treated with methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months. — 10 years
    To analyze the therapeutic effect of methimazole and the predictors of remission of hyperthyroidism after methimazole treatment.
  • Adverse effects of methimazole in the treatment of hyperthyroidism in children. Adverse effects are defined as having neutropenia (absolute neutrophil count< 1500/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al. — 1 year
    Analyze the adverse reaction of methimazole treatment in hyperthyroidism children. Explore the risk factors related to the occurrence of methimazole related adverse reactions.

Trial sites (1)

FacilityCityRegionStatus
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06570967 on ClinicalTrials.gov ↗ ← All trials in China