Autoimmune HyperthyroidismIPER6NCT07544290
Autoimmune Hyperthyroidism in Prepubertal Children
An observational study of Autoimmune Hyperthyroidism and Children, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial summary
The investigators propose a multicenter retrospective study to assess clinical, biochemical, and auxological characteristics at diagnosis and during follow-up in a cohort of Caucasian pediatric patients diagnosed with autoimmune hyperthyroidism before puberty. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Autoimmune Hyperthyroidism, Children
- What is being tested?
- restrospective observational study
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to Dec 2026
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We enrolled all patients affected by autoimmune hyperthyroidism in prepubertal age and pubertal age to compare 2 groups
Who may be able to join
- -Subjects with autoimmune hyperthyroidism
Who cannot join
- Subjects with hyperthyroidism not of autoimmune aetiology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Autoimmune Hyperthyroidism in Prepubertal Children With Onset Before 6 Years of Age: Characteristics at Diagnosis and Follow-Up Trends.
The investigators propose a multicenter retrospective study to assess clinical, biochemical, and auxological characteristics at diagnosis and during follow-up in a cohort of Caucasian pediatric patients diagnosed with autoimmune hyperthyroidism before puberty. These prepubertal patients will be compared with a control group of post-pubertal patients with Graves' disease.
This study aims to enhance the understanding of autoimmune hyperthyroidism in prepubertal patients by providing a detailed evaluation of disease onset, therapeutic response, and growth-related outcomes. The inclusion of a carefully matched post-pubertal control group will allow for robust comparative analysis and identification of age-dependent clinical patterns and prognostic indicators, ultimately supporting more tailored and effective management strategies in pediatric populations at this particular age.
Read the detailed description
There are only few studies in literature focusing on the analysis of cohorts of patients with autoimmune hyperthyroidism with onset exclusively in early childhood. The investigators therefore propose this study with the aim of retrospectively assessing characteristics at onset and during follow-up in a cohort of Caucasian hyperthyroid subjects diagnosed with the disease before puberty.
OBJECTIVES AND ENDPOINTS
- Primary Objective To evaluate the clinical and biochemical features at the onset of autoimmune hyperthyroidism in patients diagnosed in prepubertal age Secondary Objectives
- To evaluate of biochemical parameters during medical therapy
- To evaluate of auxological parameters at diagnosis and during follow-up
- To compare the previous data with the clinical and biochemical features at diagnosis and during the follow-up in patients diagnosed with Graves during the pubertal age (> Tanner 2) Inclusion Criteria 1. Subjects with autoimmune hyperthyroidism 2. Prepubertal stage (Tanner 1) at diagnosis Exclusion Criteria 3. Subjects with hyperthyroidism not of autoimmune aetiology 4. Pubertal stage (>Tanner 2) at diagnosis Sample size:
- 50 hyperthyroid subjects diagnosed with the disease before puberty
- 50 hyperthyroid subjects diagnosed with the disease during and post puberty
The data will then be analyzed using PRISM software. The principal investigator will verify the completeness, correctness, consistency and congruence of the reported data.
- Conditions
- Autoimmune Hyperthyroidism, Children
- Being tested
- restrospective observational study
- Keywords
- pubertal age, autoimmune hyperthyroidism, graves, prepubertal age, antithyroid drugs
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restrospective observational studyOther
we collect clinical, hormonal and follow up data and compare data in prepubertal and pubertal patients affected by autoimmune hyperthyroidism
| Study group | Role | What they receive |
|---|---|---|
| 50 patients affected by autoimmune hyperthyroidism in prepubertal age | Not described Receives: Other: restrospective observational study | |
| 50 patients affected by autoimmune hyperthyroidism in pubertal age | Not described Receives: Other: restrospective observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinical signs of hyperthyroidism at diagnosis
Total number of clinical signs (including goiter, exophthalmos, and tachycardia) present at diagnosis, recorded as a count per patient.
Measured: Day 0 (retrospective assessment at diagnosis)
Number of clinical symptoms at diagnosis
Total number of symptoms per patient, categorized as none (0), mild (1-2), moderate (3-5), or severe (>5).
Measured: Day 0
Serum free triiodothyronine (FT3) levels at diagnosis
Measurement of serum FT3 (pmol/L) at diagnosis.
Measured: Day 0
Serum free thyroxine (FT4) levels at diagnosis
Measurement of serum FT4 (pmol/L) at diagnosis.
Measured: Day 0
Serum thyroid-stimulating hormone (TSH) levels at diagnosis
Measurement of serum TSH (mIU/L) at diagnosis.
Measured: Day 0
Serum TSH receptor antibody (TRAb) levels at diagnosis
Measurement of TRAb levels (IU/L) at diagnosis.
Measured: Day 0
Thyroid autoantibody positivity at diagnosis (TPOAb and TgAb)
Presence or absence of thyroid autoantibodies (TPOAb and TgAb), reported as positive/negative.
Measured: Day 0
Secondary outcomes (9)
Duration of antithyroid drug therapy
Time in months from initiation of antithyroid drug therapy to treatment discontinuation or switch to definitive therapy, whichever occurs first.
Measured: Baseline (treatment initiation) to treatment discontinuation (up to 24 months)
Remission rate after antithyroid drug therapy
Proportion of patients achieving sustained normalization of thyroid function (TSH, FT3, FT4) for at least 12 months after discontinuation of therapy.
Measured: At 24 months after treatment initiation
Rate of definitive treatment (thyroidectomy or radioactive iodine therapy)
Proportion of patients requiring definitive treatment, defined as thyroidectomy or radioactive iodine therapy.
Measured: Baseline to 24 months
Serum TSH receptor antibody (TRAb) levels at time of the definitive treatment
Measurement of serum TRAb levels (IU/L) at the time of transition to definitive therapy.
Measured: At time of definitive treatment (up to 24 months)
Time to normalization of thyroid function
Time in weeks from initiation of antithyroid therapy to normalization of FT3, FT4, and TSH levels.
Measured: Baseline to normalization (up to 12 months)
Aauxological parameters at diagnosis and during follow-up
delta target height
Measured: day 0, diagnosis; at 6 months; at 12 months
Number of antithyroid drug discontinuation attempts
Number of attempts to discontinue antithyroid therapy per patient, categorized as successful or unsuccessful based on biochemical remission.
Measured: Baseline to 24 months
Annual growth velocity during follow-up
Change in height per year (cm/year).
Measured: Baseline to 24 months
Bone age during follow-up
Bone age assessed using Greulich and Pyle method.
Measured: At baseline, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HyperthyroidismStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, University of Genova, S. Anna Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera Universitaria Integrata Verona, Fondazione IRCCS San Gerardo dei Tintori, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Università di Torino, Torino, Federico II University, Buzzi Children's Hospital
- Responsible party
- Principal investigator, Vigone Maria Cristina, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544290
- Sponsor's protocol ID
- CET 164-2025
- Acronym
- IPER6
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gu Y, Liang X, Liu M, Wu D, Li W, Cao B, Li Y, Su C, Chen J, Gong C. Clinical features and predictors of remission in children under the age of 7 years with Graves' disease. Pediatr Investig. 2020 Sep 27;4(3):198-203. doi: 10.1002/ped4.12219. eCollection 2020 Sep.
PubMed 33150314Chen J, Eng L & Lam L. MON-263 Graves' disease presenting as chronic diarrhea in a toddler. Journal of the Endocrine Society 2019
Jonak O, Polubok J, Barg E. Graves' disease in 2.5 years old girl - 6-years-long observation. Pediatr Endocrinol Diabetes Metab. 2016;22(2):76-79. doi: 10.18544/PEDM-22.02.0055.
PubMed 28329777Azova S, Rajabi F, Modi BP, Mansfield L, Jonas MM, Drobysheva A, Boyd TK, Wassner AJ, Smith JR. Graves' disease in a five-month-old boy with an unusual treatment course. J Pediatr Endocrinol Metab. 2020 Dec 15;34(3):401-406. doi: 10.1515/jpem-2020-0549. Print 2021 Mar 26.
PubMed 33675208Shulman DI, Muhar I, Jorgensen EV, Diamond FB, Bercu BB, Root AW. Autoimmune hyperthyroidism in prepubertal children and adolescents: comparison of clinical and biochemical features at diagnosis and responses to medical therapy. Thyroid. 1997 Oct;7(5):755-60. doi: 10.1089/thy.1997.7.755.
PubMed 9349579Lazar L, Kalter-Leibovici O, Pertzelan A, Weintrob N, Josefsberg Z, Phillip M. Thyrotoxicosis in prepubertal children compared with pubertal and postpubertal patients. J Clin Endocrinol Metab. 2000 Oct;85(10):3678-82. doi: 10.1210/jcem.85.10.6922.
PubMed 11061522Francis N, Francis T, Lazarus JH, Okosieme OE. Current controversies in the management of Graves' hyperthyroidism. Expert Rev Endocrinol Metab. 2020 May;15(3):159-169. doi: 10.1080/17446651.2020.1754192. Epub 2020 Apr 21.
PubMed 32315207Mooij CF, Cheetham TD, Verburg FA, Eckstein A, Pearce SH, Leger J, van Trotsenburg ASP. 2022 European Thyroid Association Guideline for the management of pediatric Graves' disease. Eur Thyroid J. 2022 Jan 1;11(1):e210073. doi: 10.1530/ETJ-21-0073.
PubMed 34981748Kaplowitz PB, Vaidyanathan P. Update on pediatric hyperthyroidism. Curr Opin Endocrinol Diabetes Obes. 2020 Feb;27(1):70-76. doi: 10.1097/MED.0000000000000521.
PubMed 31789723Leger J, Olivieri A, Donaldson M, Torresani T, Krude H, van Vliet G, Polak M, Butler G; ESPE-PES-SLEP-JSPE-APEG-APPES-ISPAE; Congenital Hypothyroidism Consensus Conference Group. European Society for Paediatric Endocrinology consensus guidelines on screening, diagnosis, and management of congenital hypothyroidism. Horm Res Paediatr. 2014;81(2):80-103. doi: 10.1159/000358198. Epub 2014 Jan 21.
PubMed 24662106
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmune Hyperthyroidism in Prepubertal Children With Onset Before 6 Years of Age: Characteristics at Diagnosis and Follow-Up Trends.
- ClinicalTrials.gov ID
- NCT07544290
- Acronym / sponsor ID
- IPER6 / CET 164-2025
- Conditions
- Autoimmune Hyperthyroidism, Children
- Keywords
- pubertal age, autoimmune hyperthyroidism, graves, prepubertal age, antithyroid drugs
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, University of Genova, S. Anna Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera Universitaria Integrata Verona, Fondazione IRCCS San Gerardo dei Tintori, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Università di Torino, Torino, Federico II University, Buzzi Children's Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Apr 2026 (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.
The investigators propose a multicenter retrospective study to assess clinical, biochemical, and auxological characteristics at diagnosis and during follow-up in a cohort of Caucasian pediatric patients diagnosed with autoimmune hyperthyroidism before puberty. These prepubertal patients will be compared with a control group of post-pubertal patients with Graves' disease.
This study aims to enhance the understanding of autoimmune hyperthyroidism in prepubertal patients by providing a detailed evaluation of disease onset, therapeutic response, and growth-related outcomes. The inclusion of a carefully matched post-pubertal control group will allow for robust comparative analysis and identification of age-dependent clinical patterns and prognostic indicators, ultimately supporting more tailored and effective management strategies in pediatric populations at this particular age.
Detailed description
There are only few studies in literature focusing on the analysis of cohorts of patients with autoimmune hyperthyroidism with onset exclusively in early childhood. The investigators therefore propose this study with the aim of retrospectively assessing characteristics at onset and during follow-up in a cohort of Caucasian hyperthyroid subjects diagnosed with the disease before puberty.
OBJECTIVES AND ENDPOINTS
- Primary Objective To evaluate the clinical and biochemical features at the onset of autoimmune hyperthyroidism in patients diagnosed in prepubertal age Secondary Objectives
- To evaluate of biochemical parameters during medical therapy
- To evaluate of auxological parameters at diagnosis and during follow-up
- To compare the previous data with the clinical and biochemical features at diagnosis and during the follow-up in patients diagnosed with Graves during the pubertal age (> Tanner 2) Inclusion Criteria 1. Subjects with autoimmune hyperthyroidism 2. Prepubertal stage (Tanner 1) at diagnosis Exclusion Criteria 3. Subjects with hyperthyroidism not of autoimmune aetiology 4. Pubertal stage (>Tanner 2) at diagnosis Sample size:
- 50 hyperthyroid subjects diagnosed with the disease before puberty
- 50 hyperthyroid subjects diagnosed with the disease during and post puberty
The data will then be analyzed using PRISM software. The principal investigator will verify the completeness, correctness, consistency and congruence of the reported data.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 patients affected by autoimmune hyperthyroidism in prepubertal age | – | Other: restrospective observational study |
| 50 patients affected by autoimmune hyperthyroidism in pubertal age | – | Other: restrospective observational study |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We enrolled all patients affected by autoimmune hyperthyroidism in prepubertal age and pubertal age to compare 2 groups
Key inclusion criteria (1 listed)
- -Subjects with autoimmune hyperthyroidism
Key exclusion criteria (1 listed)
- Subjects with hyperthyroidism not of autoimmune aetiology
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 |
|---|---|---|
| restrospective observational studywe collect clinical, hormonal and follow up data and compare data in prepubertal and pubertal patients affected by autoimmune hyperthyroidism | Other | 50 patients affected by autoimmune hyperthyroidism in prepubertal age, 50 patients affected by autoimmune hyperthyroidism in pubertal age |
Primary outcome
Number of clinical signs of hyperthyroidism at diagnosis
Time frame: Day 0 (retrospective assessment at diagnosis)
Total number of clinical signs (including goiter, exophthalmos, and tachycardia) present at diagnosis, recorded as a count per patient.
Number of clinical symptoms at diagnosis
Time frame: Day 0
Total number of symptoms per patient, categorized as none (0), mild (1-2), moderate (3-5), or severe (>5).
Serum free triiodothyronine (FT3) levels at diagnosis
Time frame: Day 0
Measurement of serum FT3 (pmol/L) at diagnosis.
Serum free thyroxine (FT4) levels at diagnosis
Time frame: Day 0
Measurement of serum FT4 (pmol/L) at diagnosis.
Serum thyroid-stimulating hormone (TSH) levels at diagnosis
Time frame: Day 0
Measurement of serum TSH (mIU/L) at diagnosis.
Serum TSH receptor antibody (TRAb) levels at diagnosis
Time frame: Day 0
Measurement of TRAb levels (IU/L) at diagnosis.
Thyroid autoantibody positivity at diagnosis (TPOAb and TgAb)
Time frame: Day 0
Presence or absence of thyroid autoantibodies (TPOAb and TgAb), reported as positive/negative.
9 secondary outcomes
Duration of antithyroid drug therapy
Time frame: Baseline (treatment initiation) to treatment discontinuation (up to 24 months)
Remission rate after antithyroid drug therapy
Time frame: At 24 months after treatment initiation
Rate of definitive treatment (thyroidectomy or radioactive iodine therapy)
Time frame: Baseline to 24 months
Serum TSH receptor antibody (TRAb) levels at time of the definitive treatment
Time frame: At time of definitive treatment (up to 24 months)
Time to normalization of thyroid function
Time frame: Baseline to normalization (up to 12 months)
Aauxological parameters at diagnosis and during follow-up
Time frame: day 0, diagnosis; at 6 months; at 12 months
Number of antithyroid drug discontinuation attempts
Time frame: Baseline to 24 months
Annual growth velocity during follow-up
Time frame: Baseline to 24 months
Bone age during follow-up
Time frame: At baseline, 12 months, and 24 months
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 22 Apr 2026.
- Background: PubMed 33150314Gu Y, Liang X, Liu M, Wu D, Li W, Cao B, Li Y, Su C, Chen J, Gong C. Clinical features and predictors of remission in children under the age of 7 years with Graves' disease. Pediatr Investig. 2020 Sep 27;4(3):198-203. doi: 10.1002/ped4.12219. eCollection 2020 Sep.
- BackgroundChen J, Eng L & Lam L. MON-263 Graves' disease presenting as chronic diarrhea in a toddler. Journal of the Endocrine Society 2019
- Background: PubMed 28329777Jonak O, Polubok J, Barg E. Graves' disease in 2.5 years old girl - 6-years-long observation. Pediatr Endocrinol Diabetes Metab. 2016;22(2):76-79. doi: 10.18544/PEDM-22.02.0055.
- Background: PubMed 33675208Azova S, Rajabi F, Modi BP, Mansfield L, Jonas MM, Drobysheva A, Boyd TK, Wassner AJ, Smith JR. Graves' disease in a five-month-old boy with an unusual treatment course. J Pediatr Endocrinol Metab. 2020 Dec 15;34(3):401-406. doi: 10.1515/jpem-2020-0549. Print 2021 Mar 26.
- Background: PubMed 9349579Shulman DI, Muhar I, Jorgensen EV, Diamond FB, Bercu BB, Root AW. Autoimmune hyperthyroidism in prepubertal children and adolescents: comparison of clinical and biochemical features at diagnosis and responses to medical therapy. Thyroid. 1997 Oct;7(5):755-60. doi: 10.1089/thy.1997.7.755.
- Background: PubMed 11061522Lazar L, Kalter-Leibovici O, Pertzelan A, Weintrob N, Josefsberg Z, Phillip M. Thyrotoxicosis in prepubertal children compared with pubertal and postpubertal patients. J Clin Endocrinol Metab. 2000 Oct;85(10):3678-82. doi: 10.1210/jcem.85.10.6922.
- Background: PubMed 32315207Francis N, Francis T, Lazarus JH, Okosieme OE. Current controversies in the management of Graves' hyperthyroidism. Expert Rev Endocrinol Metab. 2020 May;15(3):159-169. doi: 10.1080/17446651.2020.1754192. Epub 2020 Apr 21.
- Background: PubMed 34981748Mooij CF, Cheetham TD, Verburg FA, Eckstein A, Pearce SH, Leger J, van Trotsenburg ASP. 2022 European Thyroid Association Guideline for the management of pediatric Graves' disease. Eur Thyroid J. 2022 Jan 1;11(1):e210073. doi: 10.1530/ETJ-21-0073.
- Background: PubMed 31789723Kaplowitz PB, Vaidyanathan P. Update on pediatric hyperthyroidism. Curr Opin Endocrinol Diabetes Obes. 2020 Feb;27(1):70-76. doi: 10.1097/MED.0000000000000521.
- Background: PubMed 24662106Leger J, Olivieri A, Donaldson M, Torresani T, Krude H, van Vliet G, Polak M, Butler G; ESPE-PES-SLEP-JSPE-APEG-APPES-ISPAE; Congenital Hypothyroidism Consensus Conference Group. European Society for Paediatric Endocrinology consensus guidelines on screening, diagnosis, and management of congenital hypothyroidism. Horm Res Paediatr. 2014;81(2):80-103. doi: 10.1159/000358198. Epub 2014 Jan 21.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Autoimmune Hyperthyroidism and Children, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 22 Apr 2026. 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinical signs of hyperthyroidism at diagnosis (time frame: Day 0 (retrospective assessment at diagnosis)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07544290, which also lists 10 linked publications.
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 22 Apr 2026.