Status:
RECRUITING
Graves' Disease Remission Study: MycoMeth Combo
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Graves' Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
A randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease.
Detailed Description
The remission rate of methimazole standard therapy in patients with newly diagnosed Graves' disease is only around 50%. Main reason for the low remission rate is methimazole therapy is not a drug targ...
Eligibility Criteria
Inclusion
- \- 1. aged 18 to 60 years.
- 2\. Patients newly diagnosed with Graves' disease.
Exclusion
- 1\. Patients with Graves' disease who have undergone treatment or experienced relapse.
- 2\. Hyperthyroidism due to other etiologies (toxic multinodular goiter, toxic thyroid adenoma, Hashimoto's thyroiditis, subacute thyroiditis, iodine-induced hyperthyroidism, etc.).
- 3\. Individuals requiring intervention for moderate to severe thyroid eye disease at the time of enrollment.
- 4\. Patients with hyperthyroidism requiring surgery due to concurrent thyroid cancer.
- 5\. Those with severe liver or kidney dysfunction (ALT or AST \> 3 times the upper limit of normal reference values, blood creatinine \> 135 mol/L for males, and 110 mol/L for females).
- 6\. Individuals with leukopenia (WBC \< 3.0×109/L).
- 7\. Patients with severe heart failure (NYHA class III or IV).
- 8\. Individuals with chronic or severe infections such as pulmonary tuberculosis, hepatitis B, etc.
- 9\. Pregnant women, breastfeeding women, those planning pregnancy in the near future, or individuals who cannot comply with contraception during trial.
- 10\. Participants in or previously involved in other clinical studies.
- 11\. Individuals unwilling or unable to comply with follow-up or unwilling to participate.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 8 2026
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06068179
Start Date
October 16 2023
End Date
October 8 2026
Last Update
February 28 2024
Active Locations (1)
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1
Xiao Fangsen
Xiamen, Fujian, China, 361003