NCT06068179 Graves' Disease Remission Study: MycoMeth Combo
| NCT ID | NCT06068179 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Graves' Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 205 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2025-10-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 205 participants in total. It began in 2023-10-16 with a primary completion date of 2025-10-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease.
Eligibility Criteria
Inclusion Criteria: \- 1. aged 18 to 60 years. 2\. Patients newly diagnosed with Graves' disease. Exclusion Criteria: * 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.
Contact & Investigator
Fangsen Xiao, MD
PRINCIPAL INVESTIGATOR
The first affiliated hospital of Xiamen University Medical College
Frequently Asked Questions
Who can join the NCT06068179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Graves' Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06068179 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06068179 currently recruiting?
Yes, NCT06068179 is actively recruiting participants. Contact the research team at xfs888@163.com for enrollment information.
Where is the NCT06068179 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT06068179 clinical trial?
NCT06068179 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Fangsen Xiao, MD at The first affiliated hospital of Xiamen University Medical College. The trial plans to enroll 205 participants.