Diabetes Mellitus, Type 1Phase 2Meld-ATGNCT04509791
MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)
A Phase 2 study testing Anti-Human Thymocyte Immunoglobulin, Rabbit in people with Diabetes Mellitus, Type 1, run by Universitaire Ziekenhuizen KU Leuven at 14 sites in 8 countries.
Trial summary
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Anti-Human Thymocyte Immunoglobulin, Rabbit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 24 Nov 2020to 16 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- has given written informed consent to participate; or have a parent or legal guardian provide written informed consent. Individual under the age of consent will be asked to assent to trial participation
- be aged > 5 years to < 25 years at written informed consent/assent
- have been diagnosed with T1d within 3-9 weeks of planned treatment day 1
- have random C-peptide levels > 200 pmol/L measured at screening, as tested centrally
- have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
- will be > 6 weeks form last live immunisation at planned treatment day 1 and be willing to forgo live vaccines during the trial until 6 months post treatment
- be willing to comply with intensive diabetes management
Who cannot join
- Type 2 diabetes
- Evidence of prior or current tuberculosis (TB) infection
- Clinically significant abnormal full blood count (FBC), renal function or liver function at screening
- Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
- any active chronic infections at screening, or any active acute or chronic infections at baseline or on treatment day, which would contraindicate any additional immunosuppression
- seropositive for human immunodeficiency virus (HIV),hepatitis B of hepatitis C infection at screening
Show all 14Show fewer
- positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) based on local testing regimen
- unwilling to use appropriate contraception if sexually active during the trial, from date of written informed consent until completion of the 12-month follow-up visit
- any history of malignancies, other than skin
- current or ongoing use of non-insulin pharmaceuticals that effect glycaemic control
- active participation in another T1D treatment interventional trial in the previous 30 days prior to screening ( excluding treatment with insulin)
- any prior treatment with ATG, Abatacept or Anti-CD3 monoclonal antibody (Anti-CD3)
- known allergy to ATG or to similar products
- any condition, complicating medical issues, or abnormal clinical laboratory results that the investigator judges may adversely affect trial conduct, cause increased risk to the participant, or compromise the trial results
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
Belgium4 sites
Universitair Ziekenhuis Antwerpen
Antwerp
Universitair ziekenhuis Brussel
Brussels
Universite Libre de Bruxelles
Brussels
Universitaire Ziekenhuizen Leuven
Leuven
United Kingdom3 sites
Cambridge University Hospitals NHS Trust
Cambridge
The Royal London Hospital - Barts Health NHS Trust
London
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxon, OX3 9DU
Austria2 sites
Medical University of Graz
Graz
Medical University of Vienna
Vienna
About this study
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D).
For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.
Read more
The MELD-ATG trial is a phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial.
- to investigate the effect of 2.5 mg/kg og ATG on the preservation of stimulated C-peptide at 12 months compared to placebo
- to identify the minimally effective dose of ATG that shows an effect on C-peptide when compared to placebo at 12 months
Read the detailed description
A phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial.
Randomisation wil be stratified by age. The trial consist of seven cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg and 0.1 mg/kg.
ATG total dose in a 1:1:1:1 allocation ratio. There will be an initial age step down selection of this cohort with recruitment starting with dose aged 12-25 years and, providing no new safety concerns are raised in the first 10 participants to receive active dose, progressing to all ages (5-25 years) The next two cohorts of 12 participants will be randomised to placebo, 2.5 mg/kg, and 2 specified middle ATG total doses in a 1:1:1:1 allocation ratio.
The next four cohorts of 15 participants will be randomised to placebo, 2.5 mg/kg, and a single selected middle ATG total doses in a 1:1:1 allocation ratio.
This design allows sequential adjustment of the middle doses to be explored following review of all safety and early efficacy data by the Independent Data Monitoring Committee ( IDMC) and Dose Determine Committee (DDC) to seek the minimum effective dose
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Anti-Human Thymocyte Immunoglobulin, Rabbit
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Human Thymocyte Immunoglobulin, RabbitDrug
Also called ATG
MELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo arm Receives: Drug: Anti-Human Thymocyte Immunoglobulin, Rabbit |
| 2.5 mg ATG/kg | Active comparator | the trial consists of 7 cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg en 0.1 mg/kg in a 1:1:1:1:1 allocation ratio Receives: Drug: Anti-Human Thymocyte Immunoglobulin, Rabbit |
| 1.5 mg ATG/kg | Active comparator | the next two cohorts of 12 participants will be randomised to placebo, 2.5 mg/Kg, and 2 specified middle ATG total doses in a 1:1:1:1 allocation ratio Receives: Drug: Anti-Human Thymocyte Immunoglobulin, Rabbit |
| 0.5 mg ATG/kg | Active comparator | The next four cohorts of 15 participants will be randomised to placebo, 2.5 mg/kg and a single selected middle ATG total dose in a 1:1:1 allocation ratio Receives: Drug: Anti-Human Thymocyte Immunoglobulin, Rabbit |
| 0.1 mg ATG/kg | Active comparator | the trial consists of 7 cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg en 0.1 mg/kg in a 1:1:1:1:1 allocation ratio Receives: Drug: Anti-Human Thymocyte Immunoglobulin, Rabbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
the area under the stimulated C-peptide response curve
Measured: over the first 2 hours of a mixed meal tolerance test (MMTT) at 12 months post treatment
Secondary outcomes (7)
the area under the stimulated C-peptide response curve
Measured: over the first 2 hours of a MMTT at baseline, 3, 6 and 12 months
dry blood spot (DBS) C-peptide measurements
Measured: at all observation times
Cluster of differentiation 4 (CD4) positive T cells and Cluster of differentiation 8 (CD8) positive T cells
Measured: over 12 months
HbA1c
Measured: over 12 months
insulin requirements
The need for insulin (units) on a daily basis
Measured: over 12 months
T1D-associated autoantibodies (glutamic acid decarboxylase antibodies (GADA), insulin auto-antibodies (IAA), IA-2 antibodies (IA-2A) and Zinc transporter 8 antibodies (ZnT8A))
The presence of T1D-associated autoantibodies
Measured: over 12 months
continuous glucose monitoring (CGM) measurements ( time in range, time above time below)
Measured: over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start24 Nov 2020
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- the trial design consists of 7 cohorts, each recruited sequentially, with between 3 and 5 treatment arms ( there will be fewer arms for later cohorts)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chantal Mathieu, MD,pHD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509791
- Sponsor's protocol ID
- S63466
- Other IDs
- 2019-003265-17, 2019
- Acronym
- Meld-ATG
- Status last verified
- Jan 2025
- First submitted
- 7 Aug 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilhelm-Benartzi CS, Miller SE, Bruggraber S, Picton D, Wilson M, Gatley K, Chhabra A, Marcovecchio ML, Hendriks AEJ, Morobe H, Chmura PJ, Bond S, Aschemeier-Fuchs B, Knip M, Tree T, Overbergh L, Pall J, Arnaud O, Haller MJ, Nitsche A, Schulte AM, Mathieu C, Mander A, Dunger D. Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes. BMJ Open. 2021 Dec 7;11(12):e053669. doi: 10.1136/bmjopen-2021-053669.
PubMed 34876434Mathieu C, Wych J, Hendriks AEJ, Van Ryckeghem L, Tree T, Chmura P, Moller C, Casteels K, Danne T, Reschke F, Smigoc Schweiger D, Battelino T, Johannesen J, Rami-Merhar B, Pieber T, De Block C, Evans M, Hilbrands R, Bosi E, Willemsen RH, Basu S, Pulkkinen MA, Knip M, Cnop M, Nitsche A, Schulte AM, Niemoller E, Peakman M, Wilhelm-Benartzi C, Gillespie D, Overbergh L, Mander AP, Marcovecchio ML; INNODIA. Minimum effective low dose of antithymocyte globulin in people aged 5-25 years with recent-onset stage 3 type 1 diabetes (MELD-ATG): a phase 2, multicentre, double-blind, randomised, placebo-controlled, adaptive dose-ranging trial. Lancet. 2025 Sep 27;406(10510):1375-1388. doi: 10.1016/S0140-6736(25)01674-5. Epub 2025 Sep 18.
PubMed 40976248
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)
- ClinicalTrials.gov ID
- NCT04509791
- Acronym / sponsor ID
- Meld-ATG / S63466
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 12 Aug 2020 (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.
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D).
For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.
The MELD-ATG trial is a phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial.
- to investigate the effect of 2.5 mg/kg og ATG on the preservation of stimulated C-peptide at 12 months compared to placebo
- to identify the minimally effective dose of ATG that shows an effect on C-peptide when compared to placebo at 12 months
Detailed description
A phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial.
Randomisation wil be stratified by age. The trial consist of seven cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg and 0.1 mg/kg.
ATG total dose in a 1:1:1:1 allocation ratio. There will be an initial age step down selection of this cohort with recruitment starting with dose aged 12-25 years and, providing no new safety concerns are raised in the first 10 participants to receive active dose, progressing to all ages (5-25 years) The next two cohorts of 12 participants will be randomised to placebo, 2.5 mg/kg, and 2 specified middle ATG total doses in a 1:1:1:1 allocation ratio.
The next four cohorts of 15 participants will be randomised to placebo, 2.5 mg/kg, and a single selected middle ATG total doses in a 1:1:1 allocation ratio.
This design allows sequential adjustment of the middle doses to be explored following review of all safety and early efficacy data by the Independent Data Monitoring Committee ( IDMC) and Dose Determine Committee (DDC) to seek the minimum effective dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- the trial design consists of 7 cohorts, each recruited sequentially, with between 3 and 5 treatment arms ( there will be fewer arms for later cohorts)
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Anti-Human Thymocyte Immunoglobulin, Rabbitplacebo arm |
| 2.5 mg ATG/kg | Active comparator | Drug: Anti-Human Thymocyte Immunoglobulin, Rabbitthe trial consists of 7 cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg en 0.1 mg/kg in a 1:1:1:1:1 allocation ratio |
| 1.5 mg ATG/kg | Active comparator | Drug: Anti-Human Thymocyte Immunoglobulin, Rabbitthe next two cohorts of 12 participants will be randomised to placebo, 2.5 mg/Kg, and 2 specified middle ATG total doses in a 1:1:1:1 allocation ratio |
| 0.5 mg ATG/kg | Active comparator | Drug: Anti-Human Thymocyte Immunoglobulin, RabbitThe next four cohorts of 15 participants will be randomised to placebo, 2.5 mg/kg and a single selected middle ATG total dose in a 1:1:1 allocation ratio |
| 0.1 mg ATG/kg | Active comparator | Drug: Anti-Human Thymocyte Immunoglobulin, Rabbitthe trial consists of 7 cohorts. The first cohort of 30 participants will be randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg en 0.1 mg/kg in a 1:1:1:1:1 allocation ratio |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- has given written informed consent to participate; or have a parent or legal guardian provide written informed consent. Individual under the age of consent will be asked to assent to trial participation
- be aged > 5 years to < 25 years at written informed consent/assent
- have been diagnosed with T1d within 3-9 weeks of planned treatment day 1
- have random C-peptide levels > 200 pmol/L measured at screening, as tested centrally
- have 1 or more diabetes-related autoantibody (GADA, IA-2A or ZnT8A) present at screening, as tested centrally
Key exclusion criteria (14 listed)
- Type 2 diabetes
- Evidence of prior or current tuberculosis (TB) infection
- Clinically significant abnormal full blood count (FBC), renal function or liver function at screening
- Requiring use of other immunosuppressive or immunomodulation agents, including chronic use of systemic steroids
- any active chronic infections at screening, or any active acute or chronic infections at baseline or on treatment day, which would contraindicate any additional immunosuppression
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 |
|---|---|---|
| Anti-Human Thymocyte Immunoglobulin, RabbitAlso: ATGMELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit) | Drug | 0.1 mg ATG/kg, 0.5 mg ATG/kg, 1.5 mg ATG/kg, 2.5 mg ATG/kg, placebo |
Primary outcome
the area under the stimulated C-peptide response curve
Time frame: over the first 2 hours of a mixed meal tolerance test (MMTT) at 12 months post treatment
7 secondary outcomes
the area under the stimulated C-peptide response curve
Time frame: over the first 2 hours of a MMTT at baseline, 3, 6 and 12 months
dry blood spot (DBS) C-peptide measurements
Time frame: at all observation times
Cluster of differentiation 4 (CD4) positive T cells and Cluster of differentiation 8 (CD8) positive T cells
Time frame: over 12 months
HbA1c
Time frame: over 12 months
insulin requirements
Time frame: over 12 months
T1D-associated autoantibodies (glutamic acid decarboxylase antibodies (GADA), insulin auto-antibodies (IAA), IA-2 antibodies (IA-2A) and Zinc transporter 8 antibodies (ZnT8A))
Time frame: over 12 months
continuous glucose monitoring (CGM) measurements ( time in range, time above time below)
Time frame: over 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Background: PubMed 34876434Wilhelm-Benartzi CS, Miller SE, Bruggraber S, Picton D, Wilson M, Gatley K, Chhabra A, Marcovecchio ML, Hendriks AEJ, Morobe H, Chmura PJ, Bond S, Aschemeier-Fuchs B, Knip M, Tree T, Overbergh L, Pall J, Arnaud O, Haller MJ, Nitsche A, Schulte AM, Mathieu C, Mander A, Dunger D. Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes. BMJ Open. 2021 Dec 7;11(12):e053669. doi: 10.1136/bmjopen-2021-053669.
- Derived from this study: PubMed 40976248Mathieu C, Wych J, Hendriks AEJ, Van Ryckeghem L, Tree T, Chmura P, Moller C, Casteels K, Danne T, Reschke F, Smigoc Schweiger D, Battelino T, Johannesen J, Rami-Merhar B, Pieber T, De Block C, Evans M, Hilbrands R, Bosi E, Willemsen RH, Basu S, Pulkkinen MA, Knip M, Cnop M, Nitsche A, Schulte AM, Niemoller E, Peakman M, Wilhelm-Benartzi C, Gillespie D, Overbergh L, Mander AP, Marcovecchio ML; INNODIA. Minimum effective low dose of antithymocyte globulin in people aged 5-25 years with recent-onset stage 3 type 1 diabetes (MELD-ATG): a phase 2, multicentre, double-blind, randomised, placebo-controlled, adaptive dose-ranging trial. Lancet. 2025 Sep 27;406(10510):1375-1388. doi: 10.1016/S0140-6736(25)01674-5. Epub 2025 Sep 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
chantal Mathieu, MD,pHD principal investigator
Universitaire Ziekenhuizen KU Leuven
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-Human Thymocyte Immunoglobulin, Rabbit in people with Diabetes Mellitus, Type 1, run by Universitaire Ziekenhuizen KU Leuven at 14 sites in 8 countries.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium, United Kingdom, Austria, Denmark, Finland and 3 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the area under the stimulated C-peptide response curve (time frame: over the first 2 hours of a mixed meal tolerance test (MMTT) at 12 months post treatment). 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 NCT04509791, which also lists 2 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 10 Jan 2025.