Graves DiseasePhase 4NCT05461820
Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
A Phase 4 study testing Methimazole in people with Graves Disease and Relapse, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease, Relapse, Treatment
- What is being tested?
- Methimazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Jul 2030
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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.
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 Nanjing Medical University
Nanjing
Xuqin Zheng, 13912902902, zhengxuqin@njmu.edu.cn
About this study
Official title: Clinical Study on the Effect of Routine Treatment and Intensive Treatment on the Regulation of Graves' Disease and the Cumulative Recurrence Two Years After Drug Withdrawal
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.
Read the detailed description
The results show that the high recurrence rate of antithyroid drugs may be related to the insufficient treatment time, the fact that thyroid autoantibodies did not turn negative when the drugs were stopped, and the thyroid volume did not shrink after treatment. However, individual differences are large, and there is no clear conclusion yet. Graves hyperthyroidism is a common organ-specific autoimmune disease, and its diagnosis mainly depends on the detection of thyroid autoantibodies, especially thyroid-stimulating receptor (TRAb). The antigens in thyroid gland include thyroglobulin (Tg), thyroid peroxidase (TPO) and sodium iodide symporter (NIS) besides thyroid stimulating receptor (TR). Graves hyperthyroidism patients were not only positive for TRAb, but also some patients were positive for anti-thyroglobulin antibody (TgAb) and anti-thyroid peroxidase antibody (TPOAb). At present, the traditional antithyroid drug treatment scheme is to adjust the dosage according to whether the thyroid function returns to normal or not, and observe the antibody turning negative at the same time, and only pay attention to whether TRAb turns negative or not. It has been found that whether TPOAb turns negative when stopping the drug can predict the recurrence after stopping the drug, suggesting that it is not only necessary to observe whether TRAb turns negative, but also to pay attention to whether other thyroid autoantibodies turn negative during the treatment of hyperthyroidism. The negative conversion of all antibodies may indicate that autoantigens are no longer exposed, and the immune balance is stable.
Methimazole (MMI) is one of the most important antithyroid drugs in the treatment of Graves' disease. It mainly blocks the synthesis of thyroid hormone by inhibiting the activity of peroxidase and reduces the production of thyroid hormone. At the same time, some studies have found that methimazole has immunomodulatory effect. Methimazole is recommended for initial treatment of first-time Graves' hyperthyroidism. 30mg/d is suitable for severe Graves' hyperthyroidism and 15mg/d is suitable for mild and moderate Graves' hyperthyroidism. Research has used blocking alternative methods to treat hyperthyroidism patients, maintaining the moderate or high dose of methimazole without decreasing, such as adding levothyroxine to treat hypothyroidism when hypothyroidism occurs, in order to suppress the immune state of Graves' disease patients. However, the research results have not found that it can reduce the recurrence rate of hyperthyroidism. Analyzing the results of these clinical studies, it is found that the use time of methimazole in some studies of blocking replacement therapy is short, and the total treatment time is only one year, and all antibodies are not required to turn negative at the end of treatment. Some studies only focus on the negative conversion of TRAb antibody, but not on the negative conversion of other antibodies such as TgAb and TPOAb.
Therefore, in this study, the intensive treatment group was treated with the inhibition substitution method of fixed middle dose methimazole plus levothyroxine, and the antibody was reduced after all turned negative, while the conventional treatment group was reduced according to whether the thyroid function was normal, so as to evaluate the effects of intensive treatment and conventional treatment on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal. At the same time, the changes of immune indexes and inflammatory factors during the regulation process were evaluated. To provide evidence for improving the clinical remission rate of Graves' hyperthyroidism and exploring the etiology of Graves' hyperthyroidism.
- Conditions
- Graves Disease, Relapse, Treatment, Drug Withdrawal
- Being tested
- Methimazole
- Medical subject headings
- Graves Disease, Recurrence, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethimazoleDrug
Also called Thyrozol
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Active comparator | 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. Receives: Drug: Methimazole |
| Intensive treatment group | Active comparator | 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. Receives: Drug: Methimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within the treatment period (average 2 years)
Secondary outcomes (4)
Cumulative recurrence rate of hyperthyroidism in conventional treatment group and intensive treatment group after stopping treatment for one year.
Patients took medicine according to the course of treatment. Relapse occurs when the thyroid function returns to hyperthyroidism within 1 years after the drug is stopped.
Measured: Up to 1 years after drug withdrawal
Effects of routine treatment and intensive treatment on titer and positive rate of thyroid autoantibodies
Thyroid function and related antibodies were detected every 4 ~ 8 weeks, and the positive rate and titers of thyroid autoantibodies (including TPOAb, TGAb and TRAb) were compared.
Measured: During treatment(average 2 years) and within 2 years after drug withdrawal
Effect of conventional therapy and intensive therapy on thyroid volume
The changes of thyroid volume during treatment and withdrawal were compared.
Measured: During treatment(average 2 years) and within 2 years after drug withdrawal
Effects of conventional therapy and intensive therapy on cytokines
The changes of cytokines before and after different treatments were compared.
Measured: During treatment(average 2 years) and within 2 years after drug withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 May 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 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.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Yang, Study chair, The First Affiliated Hospital with Nanjing Medical UniversityXuqin Zheng, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461820
- Sponsor's protocol ID
- 2016-SR-037
- Status last verified
- Dec 2023
- First submitted
- 4 May 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Routine Treatment and Intensive Treatment on the Regulation of Graves' Disease and the Cumulative Recurrence Two Years After Drug Withdrawal
- ClinicalTrials.gov ID
- NCT05461820
- Acronym / sponsor ID
- 2016-SR-037
- Conditions
- Graves Disease, Relapse, Treatment, Drug Withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 18 Jul 2022 (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.
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.
Detailed description
The results show that the high recurrence rate of antithyroid drugs may be related to the insufficient treatment time, the fact that thyroid autoantibodies did not turn negative when the drugs were stopped, and the thyroid volume did not shrink after treatment. However, individual differences are large, and there is no clear conclusion yet. Graves hyperthyroidism is a common organ-specific autoimmune disease, and its diagnosis mainly depends on the detection of thyroid autoantibodies, especially thyroid-stimulating receptor (TRAb). The antigens in thyroid gland include thyroglobulin (Tg), thyroid peroxidase (TPO) and sodium iodide symporter (NIS) besides thyroid stimulating receptor (TR). Graves hyperthyroidism patients were not only positive for TRAb, but also some patients were positive for anti-thyroglobulin antibody (TgAb) and anti-thyroid peroxidase antibody (TPOAb). At present, the traditional antithyroid drug treatment scheme is to adjust the dosage according to whether the thyroid function returns to normal or not, and observe the antibody turning negative at the same time, and only pay attention to whether TRAb turns negative or not. It has been found that whether TPOAb turns negative when stopping the drug can predict the recurrence after stopping the drug, suggesting that it is not only necessary to observe whether TRAb turns negative, but also to pay attention to whether other thyroid autoantibodies turn negative during the treatment of hyperthyroidism. The negative conversion of all antibodies may indicate that autoantigens are no longer exposed, and the immune balance is stable.
Methimazole (MMI) is one of the most important antithyroid drugs in the treatment of Graves' disease. It mainly blocks the synthesis of thyroid hormone by inhibiting the activity of peroxidase and reduces the production of thyroid hormone. At the same time, some studies have found that methimazole has immunomodulatory effect. Methimazole is recommended for initial treatment of first-time Graves' hyperthyroidism. 30mg/d is suitable for severe Graves' hyperthyroidism and 15mg/d is suitable for mild and moderate Graves' hyperthyroidism. Research has used blocking alternative methods to treat hyperthyroidism patients, maintaining the moderate or high dose of methimazole without decreasing, such as adding levothyroxine to treat hypothyroidism when hypothyroidism occurs, in order to suppress the immune state of Graves' disease patients. However, the research results have not found that it can reduce the recurrence rate of hyperthyroidism. Analyzing the results of these clinical studies, it is found that the use time of methimazole in some studies of blocking replacement therapy is short, and the total treatment time is only one year, and all antibodies are not required to turn negative at the end of treatment. Some studies only focus on the negative conversion of TRAb antibody, but not on the negative conversion of other antibodies such as TgAb and TPOAb.
Therefore, in this study, the intensive treatment group was treated with the inhibition substitution method of fixed middle dose methimazole plus levothyroxine, and the antibody was reduced after all turned negative, while the conventional treatment group was reduced according to whether the thyroid function was normal, so as to evaluate the effects of intensive treatment and conventional treatment on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal. At the same time, the changes of immune indexes and inflammatory factors during the regulation process were evaluated. To provide evidence for improving the clinical remission rate of Graves' hyperthyroidism and exploring the etiology of Graves' hyperthyroidism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Active comparator | Drug: MethimazoleAccording 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. |
| Intensive treatment group | Active comparator | Drug: MethimazoleIf 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (29 listed)
- 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
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 |
|---|---|---|
| MethimazoleAlso: ThyrozolMethimazole 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. | Drug | Conventional treatment group, Intensive treatment group |
Primary outcome
Cumulative recurrence rate between conventional treatment group and intensive treatment group after two years of withdrawal.
Time frame: Up to 2 years after drug 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.
Number of patients with no adverse reactions during the treatment of Graves' disease
Time frame: Within the treatment period (average 2 years)
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.
4 secondary outcomes
Cumulative recurrence rate of hyperthyroidism in conventional treatment group and intensive treatment group after stopping treatment for one year.
Time frame: Up to 1 years after drug withdrawal
Effects of routine treatment and intensive treatment on titer and positive rate of thyroid autoantibodies
Time frame: During treatment(average 2 years) and within 2 years after drug withdrawal
Effect of conventional therapy and intensive therapy on thyroid volume
Time frame: During treatment(average 2 years) and within 2 years after drug withdrawal
Effects of conventional therapy and intensive therapy on cytokines
Time frame: During treatment(average 2 years) and within 2 years after drug withdrawal
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 11 Dec 2023.
- Individual participant dataSharing planned: No. 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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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.
Tao Yang study chair
The First Affiliated Hospital with Nanjing Medical University
Xuqin Zheng study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methimazole in people with Graves Disease and Relapse, run by The First Affiliated Hospital with Nanjing 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 4 inclusion and 29 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 11 Dec 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xuqin Zheng (13912902902, zhengxuqin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative recurrence rate between conventional treatment group and intensive treatment group after two years of withdrawal. (time frame: Up to 2 years after drug withdrawal). 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 11 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.