Obstructive Hypertrophic CardiomyopathyPhase 3NCT05174416
A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
A Phase 3 study testing Mavacamten in people with Obstructive Hypertrophic Cardiomyopathy, run by LianBio LLC at 1 site in China.
Trial summary
Mavacamtenis a novel, small molecule, selective allosteric inhibitor of cardiac-specific myosin, for the treatment of patients with symptomatic oHCM. This study will assess the efficacy and safety of mavacamten in Chinese adults with symptomatic oHCM. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Mavacamten
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2022to 22 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years old at screening.
- Body weight is greater than 45 kg at screening.
- Has adequate acoustic windows to enable accurate TTEs
- Diagnosed with oHCM
- Has documented LVEF ≥ 55% at rest.
- Has a valid measurement of Valsalva LVOT peak gradient at screening
Show all 9Show fewer
- Has NYHA Class II or III symptoms at screening
- Female participants must not be pregnant or lactating
- Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to national, local, and institutional guidelines before the first study specific procedure.
Who cannot join
- Participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever is longer.
- Causing cardiac hypertrophy in other reasons
- Previously participated in a clinical study with mavacamten.
- Hypersensitivity to any of the components of the mavacamten formulation.
- Current treatment (within 14 days prior to screening) or planned treatment during the double-blinded treatment with a combination of beta-blockers and verapamil or a combination of beta-blockers and diltiazem.
- Has been successfully treated with invasive septal reduction
Show all 18Show fewer
- Has documented obstructive coronary artery disease
- Has known moderate or severe (as per investigator's judgment) aortic valve stenosis, constrictive pericarditis, or clinically significant congenital heart disease at screening.
- Has any acute or serious comorbid condition that, in the judgment of the investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.
- History of malignant disease within 10 years of screening
- Has safety laboratory parameters outside normal limits at screening as assessed by the local laboratory
- Has a positive serologic test at screening for infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus surface antigen.
- Known uncured COVID-19 (coronavirus disease 2019) infection or with severe complication before screening.
- Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- Prior treatment with cardio toxic agents.
- Unable to comply with the study requirements, including the number of required visits to the clinical site.
- Is a first degree relative of personnel directly affiliated with the study at the clinical study site, any study vendor, or the study sponsor.
- Identified as alcohol addicts.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Phase III, Randomized, Double-blinded, Placebo-controlled Clinical Study With A Long-term Extension to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Mavacamtenis a novel, small molecule, selective allosteric inhibitor of cardiac-specific myosin, for the treatment of patients with symptomatic oHCM. This study will assess the efficacy and safety of mavacamten in Chinese adults with symptomatic oHCM.
Read the detailed description
This is a randomized, double-blinded, placebo-controlled clinical study witha long-term extension to evaluate the efficacy and safety of mavacamten in Chinese adults with symptomatic oHCM. Approximately 81eligible participants will be enrolled and randomized in a 2:1 ratio (mavacamten:placebo). Participants will receive mavacamten or matching placebofor 30 weeks indouble-blinded manner. After 30-week double-blinded placebo-controlled treatment, eligible participants will receive mavacamten for additional 48 weeks (placebogroup: switch from placebo to mavacamten, mavacamten group: maintain on mavacamten).
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- Mavacamten, Placebo
- Keywords
- Mavacamten
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
Also called MYK-461, BMS-986327
Mavacamten Capsules
PlaceboDrug
Matching PBO capsules during placebo controlled period，and mavacamten capsules during long term extension period
| Study group | Role | What they receive |
|---|---|---|
| Mavacamten | Experimental | Mavacamten Capsules Receives: Drug: Mavacamten |
| placebo | Placebo comparator | Matching Placebo Capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient
To compare the effect of a 30-week course of mavacamten with placebo on Valsalva LVOT peak gradient as determined by Doppler echocardiography
Measured: 30 weeks
Secondary outcomes (8)
Change From Baseline to Week 30 in Resting LVOT Peak Gradient
To compare the effect of a 30-week course of mavacamten with placebo on LVOT obstruction.
Measured: 30 weeks
Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 30 mmHg at Week 30
To compare the effect of a 30-week course of mavacamten with placebo on LVOT obstruction.
Measured: 30 weeks
Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 50 mmHg at Week 30.
To compare the effect of a 30-week course of mavacamten with placebo on LVOT obstruction.
Measured: 30 weeks
Proportion of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Classification From Baseline to Week 30
To compare the effect of a 30-week course of mavacamten with placebo on clinical symptoms
Measured: 30 weeks
Change From Baseline to Week 30 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
To compare the effect of a 30-week course of Mavacamten with placebo on Participant-Reported health status individually The KCCQ (23-item version) is a patient-reported questionnaire that measures the impact of patients' CV disease or its treatment on 6 distinct domains using a 2-week recall: symptoms/signs, physical limitations, quality of life, social limitations, self-efficacy, and symptom stability (Green et al., 2000). In addition to the individual domains, 2 summary scores can be calculated from the KCCQ: the overall summary score (includes the total symptom, physical limitation, social limitations and quality of life scores) and the clinical summary score (combines the total symptom and physical limitation scales). Scores range from 0 to 100, with higher scores reflecting better health status. The KCCQ will be administered to participants as indicated.
Measured: 30 weeks
Change From Baseline to Week 30 in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
To compare the effect of a 30-week course of mavacamten on cardiac biomarkers
Measured: 30 weeks
Change From Baseline to Week 30 in Cardiac Troponin
To compare the effect of a 30-week course of mavacamten on cardiac biomarkers
Measured: 30 weeks
Change From Baseline to Week 30 in Left Ventricular (LV) Mass Index
To compare the effect of a 30-week course of mavacamten with placebo on LV mass evaluated by cardiac magnetic resonance (CMR) imaging.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start4 Jan 2022
- Primary completion6 Mar 2023
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- LianBio LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuyang Zhang, M.D., Ph.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174416
- Sponsor's protocol ID
- LB2001-301
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olivotto I, Garcia-Pavia P, Tian Z, Owens AT, Lakdawala NK MD, Balaratnam G, Zhong Y, Memaj A, Barrett YC, Desai M. Mavacamten monotherapy in obstructive hypertrophic cardiomyopathy: An integrated analysis of phase 3 clinical trials. Am Heart J. 2026 Aug 24;303:107587. doi: 10.1016/j.ahj.2026.107587. Online ahead of print.
PubMed 42636950Tian Z, Li X, Li L, Zhang Q, Wang J, Shi Y, Peng D, Ma W, Yang P, Cheng X, Jin W, Wang F, Xie Y, Pan B, Florea V, Zhang S. Long-Term Efficacy and Safety of Mavacamten in Chinese Patients With Obstructive Hypertrophic Cardiomyopathy: Week 78 Results From the EXPLORER-CN Study. J Am Heart Assoc. 2026 Jun 2;15(11):e046251. doi: 10.1161/JAHA.125.046251. Epub 2026 May 25.
PubMed 42179278Tian Z, Li X, Li L, Zhang Q, Wang J, Shi Y, Peng D, Ma W, Yang P, Cheng X, Jin W, Wang F, Memaj A, Xie Y, Pan B, Florea V, Zheng J, Zhong Y, Zhang S. Mavacamten in Chinese Patients with Obstructive Hypertrophic Cardiomyopathy: Patient-Reported Health Status Analysis up to 78 Weeks in the EXPLORER-CN Study. Cardiol Ther. 2026 Jun;15(2):185-200. doi: 10.1007/s40119-026-00449-5. Epub 2026 May 21.
PubMed 42165935Tian Z, Li L, Li X, Zhang Q, Peng D, Ma W, Yang P, Wang F, Cheng X, Fu Y, Sun J, Wang J, Zhang S. Effects of Mavacamten on Cardiac Magnetic Resonance Features in Chinese Patients With Obstructive Hypertrophic Cardiomyopathy. JACC Asia. 2025 Aug;5(8):1064-1074. doi: 10.1016/j.jacasi.2025.05.015. Epub 2025 Jul 8.
PubMed 40632050Tian Z, Li X, Li L, Zhang Q, Wang J, Shi Y, Peng D, Yang P, Ma W, Wang F, Jin W, Cheng X, Chen YM, Zhong Y, Barrett YC, Zheng J, Zhang S. Effect of Mavacamten on Echocardiographic Features in Chinese Patients with Obstructive Hypertrophic Cardiomyopathy: Results from the EXPLORER-CN Study. Cardiol Ther. 2025 Jun;14(2):267-282. doi: 10.1007/s40119-025-00409-5. Epub 2025 Apr 29.
PubMed 40299193Tian Z, Li L, Li X, Wang J, Zhang Q, Li Z, Peng D, Yang P, Ma W, Wang F, Jin W, Cheng X, Sun J, Fu Y, Lyu C, Zhang S. Effect of Mavacamten on Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy: The EXPLORER-CN Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):957-965. doi: 10.1001/jamacardio.2023.3030.
PubMed 37639259Tian Z, Wang F, Jin W, Zhang Q, Zhou J, Yang P, Wang G, Hsu P, Sun J, Zhang S, Han Y. Study design and rationale of EXPLORER-CN: a phase III, randomised, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of mavacamten in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy. BMJ Open. 2023 Jun 19;13(6):e071473. doi: 10.1136/bmjopen-2022-071473.
PubMed 37336533
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blinded, Placebo-controlled Clinical Study With A Long-term Extension to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05174416
- Acronym / sponsor ID
- LB2001-301
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Keywords
- Mavacamten
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- LianBio LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mavacamtenis a novel, small molecule, selective allosteric inhibitor of cardiac-specific myosin, for the treatment of patients with symptomatic oHCM. This study will assess the efficacy and safety of mavacamten in Chinese adults with symptomatic oHCM.
Detailed description
This is a randomized, double-blinded, placebo-controlled clinical study witha long-term extension to evaluate the efficacy and safety of mavacamten in Chinese adults with symptomatic oHCM. Approximately 81eligible participants will be enrolled and randomized in a 2:1 ratio (mavacamten:placebo). Participants will receive mavacamten or matching placebofor 30 weeks indouble-blinded manner. After 30-week double-blinded placebo-controlled treatment, eligible participants will receive mavacamten for additional 48 weeks (placebogroup: switch from placebo to mavacamten, mavacamten group: maintain on mavacamten).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mavacamten | Experimental | Drug: MavacamtenMavacamten Capsules |
| placebo | Placebo comparator | Drug: PlaceboMatching Placebo Capsules |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is at least 18 years old at screening.
- Body weight is greater than 45 kg at screening.
- Has adequate acoustic windows to enable accurate TTEs
- Diagnosed with oHCM
- Has documented LVEF ≥ 55% at rest.
Key exclusion criteria (18 listed)
- Participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever is longer.
- Causing cardiac hypertrophy in other reasons
- Previously participated in a clinical study with mavacamten.
- Hypersensitivity to any of the components of the mavacamten formulation.
- Current treatment (within 14 days prior to screening) or planned treatment during the double-blinded treatment with a combination of beta-blockers and verapamil or a combination of beta-blockers and diltiazem.
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 |
|---|---|---|
| MavacamtenAlso: MYK-461, BMS-986327Mavacamten Capsules | Drug | Mavacamten |
| PlaceboMatching PBO capsules during placebo controlled period，and mavacamten capsules during long term extension period | Drug | placebo |
Primary outcome
Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient
Time frame: 30 weeks
To compare the effect of a 30-week course of mavacamten with placebo on Valsalva LVOT peak gradient as determined by Doppler echocardiography
8 secondary outcomes
Change From Baseline to Week 30 in Resting LVOT Peak Gradient
Time frame: 30 weeks
Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 30 mmHg at Week 30
Time frame: 30 weeks
Proportion of Participants Achieving a Valsalva LVOT Peak Gradient < 50 mmHg at Week 30.
Time frame: 30 weeks
Proportion of Participants With at Least 1 Class Improvement in New York Heart Association (NYHA) Functional Classification From Baseline to Week 30
Time frame: 30 weeks
Change From Baseline to Week 30 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
Time frame: 30 weeks
Change From Baseline to Week 30 in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Time frame: 30 weeks
Change From Baseline to Week 30 in Cardiac Troponin
Time frame: 30 weeks
Change From Baseline to Week 30 in Left Ventricular (LV) Mass Index
Time frame: 30 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42636950Olivotto I, Garcia-Pavia P, Tian Z, Owens AT, Lakdawala NK MD, Balaratnam G, Zhong Y, Memaj A, Barrett YC, Desai M. Mavacamten monotherapy in obstructive hypertrophic cardiomyopathy: An integrated analysis of phase 3 clinical trials. Am Heart J. 2026 Aug 24;303:107587. doi: 10.1016/j.ahj.2026.107587. Online ahead of print.
- Derived from this study: PubMed 42179278Tian Z, Li X, Li L, Zhang Q, Wang J, Shi Y, Peng D, Ma W, Yang P, Cheng X, Jin W, Wang F, Xie Y, Pan B, Florea V, Zhang S. Long-Term Efficacy and Safety of Mavacamten in Chinese Patients With Obstructive Hypertrophic Cardiomyopathy: Week 78 Results From the EXPLORER-CN Study. J Am Heart Assoc. 2026 Jun 2;15(11):e046251. doi: 10.1161/JAHA.125.046251. Epub 2026 May 25.
- Derived from this study: PubMed 42165935Tian Z, Li X, Li L, Zhang Q, Wang J, Shi Y, Peng D, Ma W, Yang P, Cheng X, Jin W, Wang F, Memaj A, Xie Y, Pan B, Florea V, Zheng J, Zhong Y, Zhang S. Mavacamten in Chinese Patients with Obstructive Hypertrophic Cardiomyopathy: Patient-Reported Health Status Analysis up to 78 Weeks in the EXPLORER-CN Study. Cardiol Ther. 2026 Jun;15(2):185-200. doi: 10.1007/s40119-026-00449-5. Epub 2026 May 21.
- Derived from this study: PubMed 40632050Tian Z, Li L, Li X, Zhang Q, Peng D, Ma W, Yang P, Wang F, Cheng X, Fu Y, Sun J, Wang J, Zhang S. Effects of Mavacamten on Cardiac Magnetic Resonance Features in Chinese Patients With Obstructive Hypertrophic Cardiomyopathy. JACC Asia. 2025 Aug;5(8):1064-1074. doi: 10.1016/j.jacasi.2025.05.015. Epub 2025 Jul 8.
- Derived from this study: PubMed 40299193Tian Z, Li X, Li L, Zhang Q, Wang J, Shi Y, Peng D, Yang P, Ma W, Wang F, Jin W, Cheng X, Chen YM, Zhong Y, Barrett YC, Zheng J, Zhang S. Effect of Mavacamten on Echocardiographic Features in Chinese Patients with Obstructive Hypertrophic Cardiomyopathy: Results from the EXPLORER-CN Study. Cardiol Ther. 2025 Jun;14(2):267-282. doi: 10.1007/s40119-025-00409-5. Epub 2025 Apr 29.
- Derived from this study: PubMed 37639259Tian Z, Li L, Li X, Wang J, Zhang Q, Li Z, Peng D, Yang P, Ma W, Wang F, Jin W, Cheng X, Sun J, Fu Y, Lyu C, Zhang S. Effect of Mavacamten on Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy: The EXPLORER-CN Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):957-965. doi: 10.1001/jamacardio.2023.3030.
- Derived from this study: PubMed 37336533Tian Z, Wang F, Jin W, Zhang Q, Zhou J, Yang P, Wang G, Hsu P, Sun J, Zhang S, Han Y. Study design and rationale of EXPLORER-CN: a phase III, randomised, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of mavacamten in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy. BMJ Open. 2023 Jun 19;13(6):e071473. doi: 10.1136/bmjopen-2022-071473.
- 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.
Shuyang Zhang, M.D., Ph.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mavacamten in people with Obstructive Hypertrophic Cardiomyopathy, run by LianBio LLC 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 9 inclusion and 18 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 19 Sep 2024. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Week 30 in Valsalva Left Ventricular Outflow Tract (LVOT) Peak Gradient (time frame: 30 weeks). 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 NCT05174416, which also lists 7 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 19 Sep 2024.