Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT06540469
Eligibility Criteria:
Inclusion Criteria:
1. patients newly diagnosed with Graves' hyperthyroidism and not treated; or
2. patients diagnosed with Graves' hyperthyroidism and treated with ATDs regularly less than 3 months, serum TSH is measured below normal reference range, serum FT3 or FT4 or both are measured above normal reference range and serum TRAb is positive; or
3. patients diagnosed with Graves' hyperthyroidism and not regularly treated with ATDs more than 3 months, serum TSH is measured below normal reference range, serum FT3 or FT4 or both are measured above normal reference range and serum TRAb is positive.
Exclusion Criteria:
1. thyroid enlargement of grade 3;
2. serum TRAb is measured above 40IU/L;
3. moderate or severe thyroid-associated eye diseases;
4. hepatic disease history including chronic active hepatitis, severe hepatic dysfunction, liver cirrhosis, etc., and serum transaminase level is 3 times higher than the upper normal limit and/or total bilirubin level is higher than 34.2μmol/L with hepatic protective drugs;
5. history of moderate-to-severe or end-stage renal disease: eGFR\<60mL/min/1.73m2 with simplified MDRD formula;
6. serum WBC\<3.0×109／L or neutrophil count\<1.5×109／L;
7. history of severe cardiocerebrovascular disease, digestive disease, hematopoietic system disease, other autoimmune diseases in addition to Graves' hyperthyroidism, tumors, psychosis, etc.;
8. blood pressure\>180/100mmHg with regular antihypertensive drugs treatment;
9. severe comorbidities and complications of hyperthyroidism with ATDs treatment;
10. history of multiple drug allergies;
11. a family planning plan in 3 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06540469
Study Brief:
Protocol Section:
NCT06540469