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New treatment option for Graves Disease
Official title Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
ClinicalTrials.gov ID: NCT05461820
What this study is testing
What is Methimazole?
Methimazole is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for graves disease.
Also referred to as Thyrozol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, the dose of methimazole was adjusted according to the different states of thyroid function, and the effects of conventional therapy and intensive therapy on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal were evaluated. At the same time, the changes of immune indexes and inflammatory factors in the regulation process were evaluated.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Graves hyperthyroidism (responsible for doctors' clinical diagnosis)
- Age 18-65, for both men and women
- Thyroid receptor antibody (TRAb) was positive
- Take part in this research voluntarily and sign the informed consent form
You likely can't join if
- Those who have used glucocorticoid or other immunosuppressants for a long time within 3 months before being selected
- Those who have participated in any other drug trials within 3 months before being selected
- people who are participating in clinical research of other drugs
- Patients with a history of malignant tumors
- Ill-controlled hypertension: diastolic blood pressure≥100mmHg, systolic blood pressure ≥160 mmHg
- Blood routine: the total number of white blood cells \< 3.0×109 or neutrophils \< 1.5× 109
See the full eligibility criteria
- Graves hyperthyroidism (responsible for doctors' clinical diagnosis)
- Age 18-65, for both men and women
- Thyroid receptor antibody (TRAb) was positive
- Take part in this research voluntarily and sign the informed consent form
- Those who have used glucocorticoid or other immunosuppressants for a long time within 3 months before being selected
- Those who have participated in any other drug trials within 3 months before being selected
- people who are participating in clinical research of other drugs
- Patients with a history of malignant tumors
- Ill-controlled hypertension: diastolic blood pressure≥100mmHg, systolic blood pressure ≥160 mmHg
- Blood routine: the total number of white blood cells \< 3.0×109 or neutrophils \< 1.5× 109
- Other thyroid diseases: such as subacute thyroiditis, thyroid nodules, high-function adenoma
- Alanine aminotransferase(ALT) or aspartate amino transferase(AST) is greater than 2 times of the normal upper limit; When ALT or AST is less than 2 times of the normal upper limit, and the test of hepatitis B two...
- Renal insufficiency: serum creatinine is higher than the upper limit of normal value
- Patients with heart failure
- Patients with coronary heart disease
- Patients with other autoimmune diseases
- Patients who are known to be allergic to any component of this medicine are allergic to the active ingredients or any auxiliary materials in the prescription
- Patients with multiple drug allergies, allergic diseases, people with high sensitivity and drug addicts
- Alcoholism, mental disorder or other observers who are not suitable for drug testing
- Pregnant and lactating women cannot rule out the possibility of pregnancy
- Taking any medicine with unknown ingredients or using traditional Chinese medicine, the researcher judges the medicine that may affect the curative effect of hyperthyroidism
- According to the researcher's judgment, other medical history that reduces the possibility of joining the group or complicates the joining of the group, such as frequent changes in the working environment, may easily...
- The compliance of this clinical trial protocol is \ 120%;
- Those who did not meet the inclusion criteria or the exclusion criteria were found during the experiment;
- Those who can't cooperate, including those who can't complete the whole course of treatment, don't complete the follow-up as planned, and increase or decrease adjuvant drugs at will;
- During the trial, use other drugs that may affect the curative effect of this trial. Termination of Research Criteria:
- Those who are allergic or intolerant to this drug;
- Adverse reactions or serious adverse events that patients can't tolerate occur;
- Pregnant women of childbearing age in the experiment;
- Other diseases appear during the treatment, and the treatment of accompanying diseases will interfere with the clinical observers of this medicine;
- The researcher thinks it is inappropriate to continue the experiment.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.