Sponsor study identifier
interventional
240
1 country
1
Study Start
May 1, 2018
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2018
Actual (reported)May 4, 2022
Actual (reported)July 18, 2022
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cumulative recurrence rate between conventional treatment group and intensive treatment group after two years of withdrawal.
Patients took medicine according to the course of treatment. Relapse occurs when the thyroid function returns to hyperthyroidism within 2 years after the drug is stopped.
Up to 2 years after drug withdrawal
Number of patients with no adverse reactions during the treatment of Graves' disease
The patient completed the methimazole treatment, and there were no adverse reactions that needed to be stopped. Adverse reactions refer to any symptoms, syndromes or diseases that affect patients' health during clinical research and observation, and also include clinically relevant situations found in the laboratory or other diagnostic processes, such as unplanned diagnosis and treatment measures, withdrawal from research, or clinically significant laboratory examination items. Blood routine, liver function, kidney function and adverse reactions will be recorded during the follow-up.
Within the treatment period (average 2 years)
Cumulative recurrence rate of hyperthyroidism in conventional treatment group and intensive treatment group after stopping treatment for one year.
Up to 1 years after drug withdrawal
Effects of routine treatment and intensive treatment on titer and positive rate of thyroid autoantibodies
During treatment(average 2 years) and within 2 years after drug withdrawal
Effect of conventional therapy and intensive therapy on thyroid volume
During treatment(average 2 years) and within 2 years after drug withdrawal
Effects of conventional therapy and intensive therapy on cytokines
During treatment(average 2 years) and within 2 years after drug withdrawal
According to the thyroid function, if the initial free thyroxine(FT4) ≥ 3 times the normal value, the initial dose of methimazole is 30mg/ day, the thyroid function will be tested every four weeks, and the dose will be reduced when thyroid stimulating hormone(TSH) \> normal lower limit or free triiodothyronine(FT3) \< normal lower limit or FT4 \< normal lower limit. The dose will be reduced according to the clinical routine, specifically, every day (30 mg→20 mg→10 mg→5mg→2.5 mg) If the initial FT4 is less than 3 times the normal value, the initial dose of methimazole is 15mg/ day, and the thyroid function is tested every four weeks. When TSH is greater than the normal lower limit or FT3 is less than the normal lower limit or FT4 is less than the normal lower limit, the dose will be reduced according to the clinical routine, specifically every day for 24 months. If TSH \> 100 mIU/L occurs during the treatment, the reduction speed will be accelerated, and 1-2 dose levels can be skipped.
If the initial FT4≥ 3 times of normal value, the initial dose of methimazole was 30mg/ day, and the thyroid function and antibodies were detected every four weeks. When TSH≥4.2 mIU/L, the amount of methimazole began to decrease, specifically in a daily manner (30 mg→20 mg→15mg). The dose was maintained after the decrease to 15 mg. In the case of hypothyroidism, levothyroxine was added until the three antibodies (TPOAb, TGAb and TRAb) were negative. The dose was maintained for six months, and then the doses of methimazole and levothyroxine were gradually reduced until drug discontinuation (each month). If the initial FT4 was less than 3 times of normal level, the initial dose of methimazole was 15 mg/ day, and levothyroxine was added when hypothyroidism occurred. After all three antibodies were negative, the doses were gradually reduced to the point of drug discontinuation.
Methimazole used in this study was produced by Merck, Germany, and its trade name is Thyrozol. The specification of this drug is 10mg/ tablet, and its validity period is 36 months. It was approved by FDA in 2009 and listed in China in 2011.
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the First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Tao Yang
The First Affiliated Hospital with Nanjing Medical University
Xuqin Zheng
The First Affiliated Hospital with Nanjing Medical University
First Submitted
May 4, 2022
First Posted
July 18, 2022
Study Start
May 1, 2018
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Block-replacement Therapy During Radioiodine Therapy
Contact the study team to confirm eligibility.
Study Completion
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 11, 2023
Record last verified: 2023-12
The medical records of the subjects (research medical records , laboratory sheets, etc.) will be kept intact in the hospital. The project researchers, ethics committee and project funding department will be allowed to consult the medical records of the subjects. Any public report on the results of this study will not disclose the personal identity of the subjects. We will make every effort to protect the privacy of the subjects' personal medical data within the scope permitted by the laws of the People's Republic of China.
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Source: ClinicalTrials.gov.
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