Graves´ DiseaseNCT07040306
A Clinical Follow-up Study on Drug Therapy for Graves' Disease Patients in China
An observational study of Graves´ Disease, run by First Hospital of China Medical University at 1 site in China.
Trial summary
This study was a prospective follow-up study of newly diagnosed and relapsed Graves' disease patients in the Endocrinology Clinic of the First Affiliated Hospital of China Medical University. The following aspects will be studied: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves´ Disease
- What is being tested?
- Methimazole(MMI)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2012to 1 Dec 2030
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes male and female hyperthyroidism patients over the age of 18. Participants must have no history of autoimmune hepatitis, viral hepatitis, blood disease, bone marrow or liver transplantation, and complete clinical data.
Who may be able to join
- Age ≥18 years old.
- Newly diagnosed GD and GD relapses.
Who cannot join
- Patients with active infiltrative exophthalmos in GD were excluded.
- Patients with other autoimmune diseases affecting thyroid function were excluded.
- Excluding patients with combined malignancies and other serious diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Xiaochun Teng, Medical Doctor (MD), +8613704049020, tengxiaochun@126.com
About this study
Official title: A Prospective Clinical Follow-up Study of Drug Treatment in Patients With Graves' Disease
This study was a prospective follow-up study of newly diagnosed and relapsed Graves' disease patients in the Endocrinology Clinic of the First Affiliated Hospital of China Medical University. The following aspects will be studied: 1. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software; 2. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment; 3. To investigate the sensitivity and specificity of TRAb in the diagnosis of GD in China and its role in predicting recurrence; 4. After taking ATD, the serum alkaline phosphatase of GD patients will increase first and then decrease. This study will focus on analyzing the dynamic changes of this index before and after methimazole treatment, and analyze the relationship between it and thyroid function index.
- Conditions
- Graves´ Disease
- Being tested
- Methimazole(MMI)
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methimazole(MMI)Drug
Determine the enrolled GD patients and adjust the dosage of methimazole according to the 2016 American Thyroid Association guidelines. Conduct thyroid function, liver function, TRAb, and blood routine tests during outpatient follow-up to observe the treatment effect and provide medication guidance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse and remission of Graves' disease in adult treated with methimazole.
Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software.
Measured: 30 years
Adverse effects of methimazole in the treatment of Graves' disease in adult.
Adverse effects are defined as having neutropenia (absolute neutrophil count< 1800/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment
Measured: 30 years
Secondary outcomes (2)
Thyrotropin receptor antibody(TRAb)
To investigate the sensitivity and specificity of the thyrotropin receptor antibody(TRAb) in the diagnosis of GD in China and its role in predicting recurrence
Measured: 30 years
The serum alkaline phosphatase
After taking ATD, the serum alkaline phosphatase of GD patients will increase first and then decrease. This study will focus on analyzing the dynamic changes of this index before and after methimazole treatment, and analyze the relationship between it and thyroid function index
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start14 Nov 2012
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves´ DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochun Teng, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040306
- Sponsor's protocol ID
- 2019-222
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Follow-up Study of Drug Treatment in Patients With Graves' Disease
- ClinicalTrials.gov ID
- NCT07040306
- Acronym / sponsor ID
- 2019-222
- Conditions
- Graves´ Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 14 Nov 2012 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a prospective follow-up study of newly diagnosed and relapsed Graves' disease patients in the Endocrinology Clinic of the First Affiliated Hospital of China Medical University. The following aspects will be studied: 1. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software; 2. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment; 3. To investigate the sensitivity and specificity of TRAb in the diagnosis of GD in China and its role in predicting recurrence; 4. After taking ATD, the serum alkaline phosphatase of GD patients will increase first and then decrease. This study will focus on analyzing the dynamic changes of this index before and after methimazole treatment, and analyze the relationship between it and thyroid function index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes male and female hyperthyroidism patients over the age of 18. Participants must have no history of autoimmune hepatitis, viral hepatitis, blood disease, bone marrow or liver transplantation, and complete clinical data.
Key inclusion criteria (2 listed)
- Age ≥18 years old.
- Newly diagnosed GD and GD relapses.
Key exclusion criteria (3 listed)
- Patients with active infiltrative exophthalmos in GD were excluded.
- Patients with other autoimmune diseases affecting thyroid function were excluded.
- Excluding patients with combined malignancies and other serious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methimazole(MMI)Determine the enrolled GD patients and adjust the dosage of methimazole according to the 2016 American Thyroid Association guidelines. Conduct thyroid function, liver function, TRAb, and blood routine tests during outpatient follow-up to observe the treatment effect and provide medication guidance. | Drug | – |
Primary outcome
Relapse and remission of Graves' disease in adult treated with methimazole.
Time frame: 30 years
Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software.
Adverse effects of methimazole in the treatment of Graves' disease in adult.
Time frame: 30 years
Adverse effects are defined as having neutropenia (absolute neutrophil count< 1800/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment
2 secondary outcomes
Thyrotropin receptor antibody(TRAb)
Time frame: 30 years
The serum alkaline phosphatase
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Graves´ Disease
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Graves' Disease, Graves Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Active, not recruitingPhase 4
Hydroxychloroquine in Mild Graves' Orbitopathy
Graves Ophthalmopathy
RecruitingPhase 2
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves´ Disease, run by First Hospital of China Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaochun Teng, Medical Doctor (MD) (+8613704049020, tengxiaochun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse and remission of Graves' disease in adult treated with methimazole. (time frame: 30 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.