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Study on characterization of T cell activation in patients with methimazole-induced agranulocytosis and cell killing mechanism

Study on characterization of T cell activation in patients with methimazole-induced agranulocytosis and cell killing mechanism

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110054
Enrollment
Unknown
Registered
2025-09-29
Start date
2023-12-11
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agranulocytosis caused by antihyperthyroid drugs

Interventions

Hyperthyroid patients who have recovered from ATD-induced agranulocytosis and are HLA-B*38:02 (+):None
Healthy individuals carrying the HLA-B*38:02 allele:None
Hyperthyroidism patient with ATD tolerance and HLA-B*38:02 (-):None
Healthy individuals with HLA-B*38:02 (-):None

Sponsors

Fujian Medical University Affiliated Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years; 2. Subjects are diagnosed with Graves' disease (GD) based on clinical and biochemical evidence of hyperthyroidism, exophthalmos, diffuse goiter, and significantly elevated titers of autoantibodies; 3. All patients receive antithyroid drug therapy (ATDT), including methimazole (MMI) or propylthiouracil (PTU); 4. Criteria for recovery from ATD-induced agranulocytosis: (1) Granulocyte count >=1.5×10^9/L confirmed prior to ATD administration; (2) Granulocyte count falls below 0.5×10^9/L during ATD treatment, and returns to normal after discontinuation of ATD; (3) White blood cell count has been normal for at least three months at the time of enrollment; 5. Criteria for ATD tolerance: Since 80% of ATD-induced agranulocytosis cases occur within the first three months, the control group of ATD-tolerant patients consists of hyperthyroid individuals who have received ATDT for at least three months without developing agranulocytosis; 6. Healthy controls: Individuals undergoing routine health examination with no history of prior disease; 7. Informed consent obtained from patients.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Suffering from severe psychiatric disorders; 3. Received anticancer chemotherapy within 1 month of agranulocytosis onset; 4. Underwent radiotherapy within the past month; 5. Undergone bone marrow transplantation at any time; 6. Persistent infection with Epstein-Barr virus, hepatitis A virus, HIV, cytomegalovirus, or parvovirus B19; 7. Persistent sepsis; 8. Miliary tuberculosis; 9. Presence of chronic neutropenia (congenital cyclic or idiopathic); 10. Immunosuppressive therapy with cytotoxic drugs; 11. Evidence of malignant bone marrow infiltration; 12. Hematologic disorders (e.g., myelodysplastic syndromes, aplastic anemia, pancytopenia, and other blood disorders); 13. Other autoimmune diseases: e.g., systemic lupus erythematosus.

Design outcomes

Primary

MeasureTime frame
CD107a;Granzyme;Perforin;Fas Ligand;Key genes for T cell activation;

Countries

China

Contacts

Public ContactMa Li

Fujian Medical University Affiliated Union Hospital

xy18834187717@126.com+86 188 3418 7717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026