Hypercholesterolemia, Autosomal DominantNCT06535542
Integrating Whole Genome Sequencing and Digital Twins Into the Management of Hypercholesterolemia in Emiratis
A study testing Whole Genome Sequencing in people with Hypercholesterolemia, Autosomal Dominant and Hypercholesterolemia, Autosomal Recessive, run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.
Trial summary
This pilot study investigates integrating whole genome sequencing and digital twin technology for managing hypercholesterolemia in Abu Dhabi clinics. It aims to establish protocols for larger future studies and incorporate genomic insights into routine medical care. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypercholesterolemia, Autosomal Dominant, Hypercholesterolemia, Autosomal Recessive, Familial Combined Hypercholesterolemia
- What is being tested?
- Whole Genome Sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 29 Jul 2024to 15 Jul 2026
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with 2 or more LDL-C levels greater than 190 mg/dL or 5.0 mmol/L in the past 12 months
- Undiagnosed patients meeting Possible, Probable or Definitive FH criteria according to Dutch Lipid Clinic Network (DLCN) criteria (Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.)
- Patients who have not been on anti-lipidemic medication in the past 3 months
- Ages 18-55
- Emirati national
- All patients must be fluent in English or Arabic
Who cannot join
- - Patients who do not meet the above criteria
- Patients with a previous diagnosis of FH
- Patients with a progressive debilitating illness
- Patient with untreated hypothyroidism, history of proteinuria, obstructive liver disease, chronic renal failure, human immunodeficiency virus infection, or on immunosuppressant or steroid or psychiatric medications
- Patients with untreated clinical anxiety or depression (as measured by a Hospital Anxiety and Depression Scale (HADS) score of ≥ 16 on the depression subscale)
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Abu Dhabi Health Research Center
Abu Dhabi, Abu Dhabi Emirate
Salah Eldin HM Hussein, MD, 0504485852, sahussein@seha.ae
Antoniette C Cano, BSc, 0558873919, o-acano@seha.ae
About this study
Official title: A Randomized Trial of Integrating Whole Genome Sequencing and Digital Twins Into the Management of Hypercholesterolemia in Emiratis
This pilot study investigates integrating whole genome sequencing and digital twin technology for managing hypercholesterolemia in Abu Dhabi clinics. It aims to establish protocols for larger future studies and incorporate genomic insights into routine medical care.
Read the detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the Middle East, with hypercholesterolemia being a significant contributor. Genetic mechanisms of hypercholesterolemia in this region are not well understood. Autosomal dominant hypercholesterolemia is a major factor, yet only ~7% of Emiratis with familial hypercholesterolemia (FH) have these mutations. In 2013, Talmud et al. identified common variants through genome-wide association studies (GWAS) that suggest a polygenic cause for hypercholesterolemia in mutation-negative FH patients. A polygenic risk score based on 12 SNPs was validated in White European populations and is used in the UK's NHS diagnostic pipeline. Distinguishing polygenic hypercholesterolemia from FH without genetic testing is challenging. These patients exhibit familial moderate hypercholesterolemia and early coronary heart disease, with elevated LDL-C, normal triglycerides, and no tendon xanthoma. Their cardiovascular risk is similar to monogenic FH with age.
Statins, though commonly prescribed for ASCVD prevention, can cause musculoskeletal symptoms leading to poor adherence, discontinuation, elevated cholesterol, and increased cardiovascular risk. Many patients fail to achieve target LDL-C levels due to suboptimal dosing. Certain gene variants increase the risk of statin side effects.
This study seeks to integrate whole genome sequencing (WGS) technology in a clinical setting through an innovative digital twin platform. This platform allows clinicians to assess monogenic and polygenic risks in real-time and make informed statin prescribing and management decisions.
- Conditions
- Hypercholesterolemia, Autosomal Dominant, Hypercholesterolemia, Autosomal Recessive, Familial Combined Hypercholesterolemia
- Being tested
- Whole Genome Sequencing
- Keywords
- LDH, Familial Hypercholesterolemia, Whole Genome Sequencing, Digital Twins, Management of Hypercholesterolemia, Emirati, Randomized Controlled Trial, Sanger Sequencing, Predictiv Care, Genomic Medicine, Precision Medicine, Pharmacogenomics
- Medical subject headings
- Hyperlipoproteinemia Type II, Hyperlipoproteinemia Type III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Genome SequencingGenetic
Participants in this arm will have their blood sample analyzed by whole-genome sequencing (WGS) and will be given access to Predictiv™ Deoxyribonucleic acid (DNA)-based digital twin platform, a web-based interactive application with WGS results. The platform will include positive monogenic and polygenic Familial Hypercholesterolemia results and pharmacogenomics results on statins and clopidogrel. A report of positive monogenic variants will be included in their medical record. This may also include genes on the American College of Medical Genetics and Genomics (ACMG) secondary findings (SF) version 3.2 list if the participant consents to receive these incidental findings. The report will only include pathogenic, likely pathogenic, and variant of uncertain significance (VUS) results.
| Study group | Role | What they receive |
|---|---|---|
| WGS + Digital Twin Group | Experimental | 20 participants who are randomized to have whole-genome sequencing performed on their sample and given access to Predictiv™ Digital Twin. These participants will meet with a genetic counselor for results disclosure and training to access the Predictiv™ Digital Twin platform. Receives: Genetic: Whole Genome Sequencing |
| Standard of Care Group | No intervention | 20 participants who are randomized to not have whole-genome sequencing performed on their sample. These participants will have standard-of-care familial hypercholesterolemia (FH) evaluation using medical history and family history only. They will not receive genetic results or Predictiv™ Digital Twin results as part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic capabilities
Diagnostic yield of standard-of-care (based on medical and family history) versus whole genome sequencing (WGS) for identifying monogenic and polygenic familial hypercholesterolemia.
Measured: From consent date until first documented report, up to 6 months
Secondary outcomes (6)
Prognostic capabilities of standard-of-care
Prognostic capabilities of standard-of-care (based on medical and family history) versus whole genome sequencing for predicting outcomes and management in monogenic and polygenic familial hypercholesterolemia.
Measured: Baseline to End of Study, up to 12 months
Resources Implementation for WGS in a clinical setting
Assessed by documenting resources necessary for each phase, including execution of WGS, reporting of results, and overall evaluation,
Measured: Baseline to End of Study, up to 12 months
Participant characteristics
Age, sociodemographic, personal and family history
Measured: Baseline
Change in Perceived Utility
Assessed using novel participant surveys via questions including: attitudes towards DNA testing and results, understanding of results, change in expectations, confidence, concerns.
Measured: Baseline, post-disclosure of results (approximately 2-3 months after enrollment), 6 months post-enrollment
Changes in Health Care Utilization
Assessed by reviewing medical records comparing number of services and procedures received related to the diagnosis.
Measured: Baseline to End of Study, up to 12 months
Clinician Attitudes About WGS
A self-built survey was created to assess physicians' perspective and attitude toward WGS
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start29 Jul 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypercholesterolemia, Autosomal DominantStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial of whole-genome sequencing.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abu Dhabi Health Services Company
- Sponsor type
- Other government
- Collaborators
- Predictiv Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Abdulmajeed BS Alzubaidi, MD, Principal investigator, Abu Dhabi Health Services Co. -SEHAErik J Koornneef, PHD, Study director, Abu Dhabi Health Services Co. -SEHAMhy-Lanie Adduru, MD, Study director, Predictiv Care, Inc.Salah Eldin HM Hu, MD, Study chair, Abu Dhabi Health Services Co. -SEHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535542
- Sponsor's protocol ID
- WGS_DT_2023
- Other IDs
- DOH/CVDC/2023/926
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data requests can be submitted 9 months after article publication, and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis.
Publications
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PubMed 16204405Wang J, Dron JS, Ban MR, Robinson JF, McIntyre AD, Alazzam M, Zhao PJ, Dilliott AA, Cao H, Huff MW, Rhainds D, Low-Kam C, Dube MP, Lettre G, Tardif JC, Hegele RA. Polygenic Versus Monogenic Causes of Hypercholesterolemia Ascertained Clinically. Arterioscler Thromb Vasc Biol. 2016 Dec;36(12):2439-2445. doi: 10.1161/ATVBAHA.116.308027. Epub 2016 Oct 20.
PubMed 27765764Futema M, Bourbon M, Williams M, Humphries SE. Clinical utility of the polygenic LDL-C SNP score in familial hypercholesterolemia. Atherosclerosis. 2018 Oct;277:457-463. doi: 10.1016/j.atherosclerosis.2018.06.006.
PubMed 30270085Talmud PJ, Shah S, Whittall R, Futema M, Howard P, Cooper JA, Harrison SC, Li K, Drenos F, Karpe F, Neil HA, Descamps OS, Langenberg C, Lench N, Kivimaki M, Whittaker J, Hingorani AD, Kumari M, Humphries SE. Use of low-density lipoprotein cholesterol gene score to distinguish patients with polygenic and monogenic familial hypercholesterolaemia: a case-control study. Lancet. 2013 Apr 13;381(9874):1293-301. doi: 10.1016/S0140-6736(12)62127-8. Epub 2013 Feb 22.
PubMed 23433573Rimbert A, Daggag H, Lansberg P, Buckley A, Viel M, Kanninga R, Johansson L, Dullaart RPF, Sinke R, Al Tikriti A, Kuivenhoven JA, Barakat MT. Low Detection Rates of Genetic FH in Cohort of Patients With Severe Hypercholesterolemia in the United Arabic Emirates. Front Genet. 2022 Jan 3;12:809256. doi: 10.3389/fgene.2021.809256. eCollection 2021.
PubMed 35047021Bamimore MA, Zaid A, Banerjee Y, Al-Sarraf A, Abifadel M, Seidah NG, Al-Waili K, Al-Rasadi K, Awan Z. Familial hypercholesterolemia mutations in the Middle Eastern and North African region: a need for a national registry. J Clin Lipidol. 2015 Mar-Apr;9(2):187-94. doi: 10.1016/j.jacl.2014.11.008. Epub 2014 Nov 29.
PubMed 25911074
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Integrating Whole Genome Sequencing and Digital Twins Into the Management of Hypercholesterolemia in Emiratis
- ClinicalTrials.gov ID
- NCT06535542
- Acronym / sponsor ID
- WGS_DT_2023
- Conditions
- Hypercholesterolemia, Autosomal Dominant, Hypercholesterolemia, Autosomal Recessive, Familial Combined Hypercholesterolemia
- Keywords
- LDH, Familial Hypercholesterolemia, Whole Genome Sequencing, Digital Twins, Management of Hypercholesterolemia, Emirati, Randomized Controlled Trial, Sanger Sequencing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abu Dhabi Health Services CompanyOther government
- Collaborators
- Predictiv Care, Inc.
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 2 Aug 2024 (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 pilot study investigates integrating whole genome sequencing and digital twin technology for managing hypercholesterolemia in Abu Dhabi clinics. It aims to establish protocols for larger future studies and incorporate genomic insights into routine medical care.
Detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the Middle East, with hypercholesterolemia being a significant contributor. Genetic mechanisms of hypercholesterolemia in this region are not well understood. Autosomal dominant hypercholesterolemia is a major factor, yet only ~7% of Emiratis with familial hypercholesterolemia (FH) have these mutations. In 2013, Talmud et al. identified common variants through genome-wide association studies (GWAS) that suggest a polygenic cause for hypercholesterolemia in mutation-negative FH patients. A polygenic risk score based on 12 SNPs was validated in White European populations and is used in the UK's NHS diagnostic pipeline. Distinguishing polygenic hypercholesterolemia from FH without genetic testing is challenging. These patients exhibit familial moderate hypercholesterolemia and early coronary heart disease, with elevated LDL-C, normal triglycerides, and no tendon xanthoma. Their cardiovascular risk is similar to monogenic FH with age.
Statins, though commonly prescribed for ASCVD prevention, can cause musculoskeletal symptoms leading to poor adherence, discontinuation, elevated cholesterol, and increased cardiovascular risk. Many patients fail to achieve target LDL-C levels due to suboptimal dosing. Certain gene variants increase the risk of statin side effects.
This study seeks to integrate whole genome sequencing (WGS) technology in a clinical setting through an innovative digital twin platform. This platform allows clinicians to assess monogenic and polygenic risks in real-time and make informed statin prescribing and management decisions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial of whole-genome sequencing.
| Arm | Type | Receives |
|---|---|---|
| WGS + Digital Twin Group | Experimental | Genetic: Whole Genome Sequencing20 participants who are randomized to have whole-genome sequencing performed on their sample and given access to Predictiv™ Digital Twin. These participants will meet with a genetic counselor for results disclosure and training to access the Predictiv™ Digital Twin platform. |
| Standard of Care Group | No intervention | –20 participants who are randomized to not have whole-genome sequencing performed on their sample. These participants will have standard-of-care familial hypercholesterolemia (FH) evaluation using medical history and family history only. They will not receive genetic results or Predictiv™ Digital Twin results as part of this study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with 2 or more LDL-C levels greater than 190 mg/dL or 5.0 mmol/L in the past 12 months
- Undiagnosed patients meeting Possible, Probable or Definitive FH criteria according to Dutch Lipid Clinic Network (DLCN) criteria (Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.)
- Patients who have not been on anti-lipidemic medication in the past 3 months
- Ages 18-55
- Emirati national
Key exclusion criteria (6 listed)
- - Patients who do not meet the above criteria
- Patients with a previous diagnosis of FH
- Patients with a progressive debilitating illness
- Patient with untreated hypothyroidism, history of proteinuria, obstructive liver disease, chronic renal failure, human immunodeficiency virus infection, or on immunosuppressant or steroid or psychiatric medications
- Patients with untreated clinical anxiety or depression (as measured by a Hospital Anxiety and Depression Scale (HADS) score of ≥ 16 on the depression subscale)
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 |
|---|---|---|
| Whole Genome SequencingParticipants in this arm will have their blood sample analyzed by whole-genome sequencing (WGS) and will be given access to Predictiv™ Deoxyribonucleic acid (DNA)-based digital twin platform, a web-based interactive application with WGS results. The platform will include positive monogenic and polygenic Familial Hypercholesterolemia results and pharmacogenomics results on statins and clopidogrel. A report of positive monogenic variants will be included in their medical record. This may also include genes on the American College of Medical Genetics and Genomics (ACMG) secondary findings (SF) version 3.2 list if the participant consents to receive these incidental findings. The report will only include pathogenic, likely pathogenic, and variant of uncertain significance (VUS) results. | Genetic | WGS + Digital Twin Group |
Primary outcome
Diagnostic capabilities
Time frame: From consent date until first documented report, up to 6 months
Diagnostic yield of standard-of-care (based on medical and family history) versus whole genome sequencing (WGS) for identifying monogenic and polygenic familial hypercholesterolemia.
6 secondary outcomes
Prognostic capabilities of standard-of-care
Time frame: Baseline to End of Study, up to 12 months
Resources Implementation for WGS in a clinical setting
Time frame: Baseline to End of Study, up to 12 months
Participant characteristics
Time frame: Baseline
Change in Perceived Utility
Time frame: Baseline, post-disclosure of results (approximately 2-3 months after enrollment), 6 months post-enrollment
Changes in Health Care Utilization
Time frame: Baseline to End of Study, up to 12 months
Clinician Attitudes About WGS
Time frame: Baseline
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 25 Mar 2025.
- Background: PubMed 16204405Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Background: PubMed 27765764Wang J, Dron JS, Ban MR, Robinson JF, McIntyre AD, Alazzam M, Zhao PJ, Dilliott AA, Cao H, Huff MW, Rhainds D, Low-Kam C, Dube MP, Lettre G, Tardif JC, Hegele RA. Polygenic Versus Monogenic Causes of Hypercholesterolemia Ascertained Clinically. Arterioscler Thromb Vasc Biol. 2016 Dec;36(12):2439-2445. doi: 10.1161/ATVBAHA.116.308027. Epub 2016 Oct 20.
- Background: PubMed 30270085Futema M, Bourbon M, Williams M, Humphries SE. Clinical utility of the polygenic LDL-C SNP score in familial hypercholesterolemia. Atherosclerosis. 2018 Oct;277:457-463. doi: 10.1016/j.atherosclerosis.2018.06.006.
- Background: PubMed 23433573Talmud PJ, Shah S, Whittall R, Futema M, Howard P, Cooper JA, Harrison SC, Li K, Drenos F, Karpe F, Neil HA, Descamps OS, Langenberg C, Lench N, Kivimaki M, Whittaker J, Hingorani AD, Kumari M, Humphries SE. Use of low-density lipoprotein cholesterol gene score to distinguish patients with polygenic and monogenic familial hypercholesterolaemia: a case-control study. Lancet. 2013 Apr 13;381(9874):1293-301. doi: 10.1016/S0140-6736(12)62127-8. Epub 2013 Feb 22.
- Background: PubMed 35047021Rimbert A, Daggag H, Lansberg P, Buckley A, Viel M, Kanninga R, Johansson L, Dullaart RPF, Sinke R, Al Tikriti A, Kuivenhoven JA, Barakat MT. Low Detection Rates of Genetic FH in Cohort of Patients With Severe Hypercholesterolemia in the United Arabic Emirates. Front Genet. 2022 Jan 3;12:809256. doi: 10.3389/fgene.2021.809256. eCollection 2021.
- Background: PubMed 25911074Bamimore MA, Zaid A, Banerjee Y, Al-Sarraf A, Abifadel M, Seidah NG, Al-Waili K, Al-Rasadi K, Awan Z. Familial hypercholesterolemia mutations in the Middle Eastern and North African region: a need for a national registry. J Clin Lipidol. 2015 Mar-Apr;9(2):187-94. doi: 10.1016/j.jacl.2014.11.008. Epub 2014 Nov 29.
- The Human Genome Project Completion: Frequently Asked Questions.Link provided by the sponsor.
- Catalog of Published Genome-Wide Association Studies.Link provided by the sponsor.
- Checklists for improving rigour in qualitative research: a case of the tail wagging the dog?Link provided by the sponsor.
- The West Midland Familial Hypercholesterolaemia (FH) screening programme: Evaluating the utility of the 12 SNP polygenic risk score (PRS) across ethnic groupingsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data requests can be submitted 9 months after article publication, and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis.
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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.
Abdulmajeed BS Alzubaidi, MD principal investigator
Abu Dhabi Health Services Co. -SEHA
Erik J Koornneef, PHD study director
Abu Dhabi Health Services Co. -SEHA
Mhy-Lanie Adduru, MD study director
Predictiv Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Genome Sequencing in people with Hypercholesterolemia, Autosomal Dominant and Hypercholesterolemia, Autosomal Recessive, run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.
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 6 inclusion and 6 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 25 Mar 2025. 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 United Arab Emirates. 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?
Contact Alina Naeem, MBBS (+97124102534, alnaeem@seha.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic capabilities (time frame: From consent date until first documented report, up to 6 months). 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 NCT06535542, which also lists 6 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 25 Mar 2025.