NCT05461820 Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
| NCT ID | NCT05461820 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Graves Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2018-05-01 |
| Primary Completion | 2023-12-31 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 240 participants in total. It began in 2018-05-01 with a primary completion date of 2023-12-31.
⚠ 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
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. This study is a phase IV clinical study designed and carried out by the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), which is a randomized, open and routine treatment group with parallel control.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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 * Subjects 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 half-and-half positive * 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 lead to lost follow-up. Rejection Criteria: * The compliance of this clinical trial protocol is \< 80% or \> 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.
Contact & Investigator
Tao Yang
STUDY CHAIR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT05461820 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 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 NCT05461820 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05461820 currently recruiting?
Yes, NCT05461820 is actively recruiting participants. Contact the research team at zhengxuqin@njmu.edu.cn for enrollment information.
Where is the NCT05461820 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05461820 clinical trial?
NCT05461820 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Tao Yang at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 240 participants.