CirrhosisPhase 3CIBERbBECHONCT05769868
Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments
A Phase 3 study testing Esmolol Injection [Brevibloc] in people with Cirrhosis and Diabetes Mellitus, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 6 sites in Spain.
Trial summary
The purpose of this study is to assess the superiority of esmolol echocardiography over conventional echocardiography in the diagnosis of subclinical myocardial involvement associated with diabetes mellitus 2, cirrhosis and antineoplastic treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Diabetes Mellitus, Oncologic Disorders
- What is being tested?
- Esmolol Injection [Brevibloc]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesSpain
- Study dates
- 18 Apr 2023to Sep 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Absence of previous heart disease, defined as the absence of relevant cardiac structural alterations such as moderate or severe hypertrophy, alteration of segmental contraction, Moderate or severe valvular disease, intraventricular obstructive gradient, or old myocardial infarction.
- Existence of an at least acceptable ultrasonic window, which allows the visualization of at least 14 of the 17 segments of the LV myocardium.
- Sinus rhythm, with a basal heart rate greater than 50 bpm.
- Diabetic patients with a diagnosis of Diabetes Mellitus 2 (DM2) with or without Heart Failure with Normal Ejection Fraction (HFNEF) (n = 300) will be included. Previous diagnosis of HFNEF with clinical stability at the time of inclusion (n = 200). No previous diagnosis of HFNEF (n = 100).
- 200 patients with cirrhosis stratified by the following additional criteria will be included: Child-Pugh A class (n = 25); Child-Pugh B class (n = 75); Child-Pugh C class (with and without ascites n = 50 and n = 50, respectively).
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- 300 cancer patients will be included, divided into 3 therapeutic groups: 125 patients diagnosed with Lymphoma or Sarcoma receiving chemotherapy based on anthracyclines at high doses (≥ 240 mg / m2); 125 patients with Human Epidermal growth factor Receptor 2 (HER2) positive breast cancer receiving chemotherapy regimen that includes trastuzumab without anthracyclines; 50 patients with hepatocarcinoma receiving treatment with Sorafenib.
- Expected survival> 6 months, first-diagnosis of cancer, and receiving treatment with chemotherapy that includes any of the previous schemes.
- A control group (n = 200) without heart disease and without any of the study conditions will be included: diabetes from any cause, cancer or active cancer treatment or some degree of liver disease.
Who cannot join
- Contraindication for the administration of esmolol (according to technical data sheet): Hypersensitivity to esmolol hydrochloride; Severe sinus bradycardia (HR <50 bpm); 2nd or 3rd degree atrioventricular block without pacemaker; Cardiogenic shock, severe hypotension, or decompensated heart failure; Untreated pheochromocytoma; Acute asthmatic attack; Concomitant intravenous administration or within the first 48 hours after verapamil.
- Treatment with beta-blocker drugs (oral, topical or intravenous) in the last 7 days before the study.
- History of ventricular or supraventricular arrhythmias that prevent the safe withdrawal of antiarrhythmic or braking treatment before the administration of esmolol.
- History of previous high-grade atrioventricular (AV) conduction disorder in non-pacemaker patients.
- Severe asthma with bronchial hyperresponsiveness.
- Patients with acute infection.
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- Participants in other clinical trials in the 30 days prior to the start of the study.
- Pregnant women, or who plan to be, and women during breastfeeding.
- Patients with limitation to follow the protocol for any reason.
- Diagnosis of Diabetes Mellitus (DM) of any type other than type 2 [type 1, Latent Autoimmune Diabetes in Adults (LADA), Maturity-Onset Diabetes of the Young (MODY), New Onset Diabetes After Transplant (NODAT), etc.]
- Patients in New York Heart Association (NYHA) functional class IV or with advanced heart failure.
- Treatment with an oral beta-blocker at the time of the examination that cannot be safely temporarily suspended 72 hours before the test.
- Active evidence of Hepatitis B Virus (HBV) or Hepatitis B Virus (HCV) infection.
- Personal history of previous cancer requiring systemic treatment (excludes skin or localized cancers treated locally surgically).
- Previous exposure to systemic antitumor treatment or radiotherapy on the thoracic region.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
José F Rodríguez Palomares, MD, PhD, +34 932746134, jfrodriguezpalomares@gmail.com
- Not yet recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Marta Sitges Carreño, MD, PhD, +34 932275722, msitges@clinic.cat
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Javier Bermejo Thomas, MD, PhD, +34 915868279, javier.bermejo@salud.madrid.org
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Esther Pérez David, MD, PhD, +34 639607988, eperezdavid@gmail.com
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, 37007
Candelas Pérez del Villar Moro, MD, +34 620778540, cperezdelvillar@gmail.com
- Not yet recruiting
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
Jaume Agüero Ramón-Llin, MD, PhD, +34 629378483, jaimeaguero30@hotmail.com
About this study
Official title: Prospective, Multicenter and Open Study to Evaluate the Efficacy of Esmolol in the Early Identification of Cardiovascular Disorders Induced by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments
The purpose of this study is to assess the superiority of esmolol echocardiography over conventional echocardiography in the diagnosis of subclinical myocardial involvement associated with diabetes mellitus 2, cirrhosis and antineoplastic treatments.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 10 days screening period to determine eligibility for study entry. At Baseline, patients who meet the eligibility requirements will be allocate in one of the 4 cohorts according to their medical conditions.
Trial design consists in a Screening period, Baseline, and 6 additional visits until Month-36.
All patients will undergo to a conventional echocardiography and echocardiography with esmolol administration at Baseline. This procedure will be performed at the following visits according their cohort.
Other complementary procedures will be the collection of blood samples to determine biomarkers, as well as hematology and biochemistry, vital signs and another explorations.
- Conditions
- Cirrhosis, Diabetes Mellitus, Oncologic Disorders
- Being tested
- Esmolol Injection [Brevibloc]
- Keywords
- beta blockers, echocardiography, esmolol, systolic function, cardiovascular diagnosis, biomarkers, diagnostic techniques, medical imaging
- Medical subject headings
- Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol Injection [Brevibloc]Drug
Also called Anatomical Therapeutic Chemical (ATC) code: C07AB09, Esmolol Hydrochloride
Brevibloc® will be administered intravenously by infusion pump following the administration schedule:
Loading dose of 500 μg/kg for 1 minute, followed by a maintenance infusion of 50 μg/kg/minute over 5 minutes.
If the target response is not obtained, the loading dose is repeated and the 50 dose is increased by 50 μg/kg/minute to a maximum of 200 μg/kg/minute.
The objective response to esmolol beta-blockade is defined as a 15-20% reduction in heart rate, with lower limits of 55 bpm and a systolic blood pressure not less than 90 mmHg and diastolic blood pressure not less than 50 mmHg.
The perfusion is kept active while the echocardiography image acquisition is completed (approx. 15-30 min).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 1 conventional echocardiography without esmolol administration followed by 1 echocardiography with esmolol administration at Baseline and other study visits. Receives: Drug: Esmolol Injection [Brevibloc] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricle (LV) ejection fraction
Estimated with 3D echocardiography (Both: convectional and with esmolol administration)
Measured: At Baseline (Day 1) until Month-24 according to cohort
Peak measurement of global LV systolic longitudinal strain
Estimated with 3D echocardiography (Both: convectional and with esmolol administration)
Measured: At Baseline (Day 1) until Month-24 according to cohort
Ejection Intraventricular Pressure Difference (EIVPD) measure
Estimated with M-mode echocardiography (Both: convectional and with esmolol administration)
Measured: At Baseline (Day 1) until Month-24 according to cohort
Secondary outcomes (9)
Ejection fraction
Obtained with 2D echocardiography (Simpson's biplane method)
Measured: At Baseline (Day 1) until Month-24 according to cohort
Interleukin (IL)-1β
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
High-sensitivity IL-6 (hsIL-6)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
Soluble Suppression of Tumorigenicity 2 (ST-2)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
N-terminal fragment of brain natriuretic peptide (NT-proBNP)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
Ultrasensitive troponin I (hsTnI)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
Procollagen type I terminal propeptide (PICP)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
C-terminal telopeptide collagen type I (CITP)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
Matrix metalloproteinase-1 (MMP-1)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Measured: At Baseline (Day 1) until Month-24 according to cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start18 Apr 2023
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Javier Bermejo Thomas, MD, PhD, Principal investigator, Hospital Universitario Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769868
- Sponsor's protocol ID
- ICI20/00011
- Other IDs
- 2021-003889-12
- Acronym
- CIBERbBECHO
- Status last verified
- Sep 2024
- First submitted
- 15 Feb 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yotti R, Bermejo J, Benito Y, Sanz-Ruiz R, Ripoll C, Martinez-Legazpi P, del Villar CP, Elizaga J, Gonzalez-Mansilla A, Barrio A, Banares R, Fernandez-Aviles F. Validation of noninvasive indices of global systolic function in patients with normal and abnormal loading conditions: a simultaneous echocardiography pressure-volume catheterization study. Circ Cardiovasc Imaging. 2014 Jan;7(1):164-72. doi: 10.1161/CIRCIMAGING.113.000722. Epub 2013 Oct 30.
PubMed 24173273Yotti R, Bermejo J, Desco MM, Antoranz JC, Rojo-Alvarez JL, Cortina C, Allue C, Rodriguez-Abella H, Moreno M, Garcia-Fernandez MA. Doppler-derived ejection intraventricular pressure gradients provide a reliable assessment of left ventricular systolic chamber function. Circulation. 2005 Sep 20;112(12):1771-9. doi: 10.1161/CIRCULATIONAHA.104.485128.
PubMed 16172285Yotti R, Ripoll C, Benito Y, Catalina MV, Elizaga J, Rincon D, Fernandez-Aviles F, Bermejo J, Banares R. Left ventricular systolic function is associated with sympathetic nervous activity and markers of inflammation in cirrhosis. Hepatology. 2017 Jun;65(6):2019-2030. doi: 10.1002/hep.29104. Epub 2017 Apr 28.
PubMed 28195341
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter and Open Study to Evaluate the Efficacy of Esmolol in the Early Identification of Cardiovascular Disorders Induced by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments
- ClinicalTrials.gov ID
- NCT05769868
- Acronym / sponsor ID
- CIBERbBECHO / ICI20/00011
- Conditions
- Cirrhosis, Diabetes Mellitus, Oncologic Disorders
- Keywords
- beta blockers, echocardiography, esmolol, systolic function, cardiovascular diagnosis, biomarkers, diagnostic techniques, medical imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Mar 2023 (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 purpose of this study is to assess the superiority of esmolol echocardiography over conventional echocardiography in the diagnosis of subclinical myocardial involvement associated with diabetes mellitus 2, cirrhosis and antineoplastic treatments.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 10 days screening period to determine eligibility for study entry. At Baseline, patients who meet the eligibility requirements will be allocate in one of the 4 cohorts according to their medical conditions.
Trial design consists in a Screening period, Baseline, and 6 additional visits until Month-36.
All patients will undergo to a conventional echocardiography and echocardiography with esmolol administration at Baseline. This procedure will be performed at the following visits according their cohort.
Other complementary procedures will be the collection of blood samples to determine biomarkers, as well as hematology and biochemistry, vital signs and another explorations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Esmolol Injection [Brevibloc]1 conventional echocardiography without esmolol administration followed by 1 echocardiography with esmolol administration at Baseline and other study visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Absence of previous heart disease, defined as the absence of relevant cardiac structural alterations such as moderate or severe hypertrophy, alteration of segmental contraction, Moderate or severe valvular disease, intraventricular obstructive gradient, or old myocardial infarction.
- Existence of an at least acceptable ultrasonic window, which allows the visualization of at least 14 of the 17 segments of the LV myocardium.
- Sinus rhythm, with a basal heart rate greater than 50 bpm.
- Diabetic patients with a diagnosis of Diabetes Mellitus 2 (DM2) with or without Heart Failure with Normal Ejection Fraction (HFNEF) (n = 300) will be included. Previous diagnosis of HFNEF with clinical stability at the time of inclusion (n = 200). No previous diagnosis of HFNEF (n = 100).
Key exclusion criteria (15 listed)
- Contraindication for the administration of esmolol (according to technical data sheet): Hypersensitivity to esmolol hydrochloride; Severe sinus bradycardia (HR <50 bpm); 2nd or 3rd degree atrioventricular block without pacemaker; Cardiogenic shock, severe hypotension, or decompensated heart failure; Untreated pheochromocytoma; Acute asthmatic attack; Concomitant intravenous administration or within the first 48 hours after verapamil.
- Treatment with beta-blocker drugs (oral, topical or intravenous) in the last 7 days before the study.
- History of ventricular or supraventricular arrhythmias that prevent the safe withdrawal of antiarrhythmic or braking treatment before the administration of esmolol.
- History of previous high-grade atrioventricular (AV) conduction disorder in non-pacemaker patients.
- Severe asthma with bronchial hyperresponsiveness.
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 |
|---|---|---|
| Esmolol Injection [Brevibloc]Also: Anatomical Therapeutic Chemical (ATC) code: C07AB09, Esmolol HydrochlorideBrevibloc® will be administered intravenously by infusion pump following the administration schedule: Loading dose of 500 μg/kg for 1 minute, followed by a maintenance infusion of 50 μg/kg/minute over 5 minutes. If the target response is not obtained, the loading dose is repeated and the 50 dose is increased by 50 μg/kg/minute to a maximum of 200 μg/kg/minute. The objective response to esmolol beta-blockade is defined as a 15-20% reduction in heart rate, with lower limits of 55 bpm and a systolic blood pressure not less than 90 mmHg and diastolic blood pressure not less than 50 mmHg. The perfusion is kept active while the echocardiography image acquisition is completed (approx. 15-30 min). | Drug | Single Arm |
Primary outcome
Left Ventricle (LV) ejection fraction
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Estimated with 3D echocardiography (Both: convectional and with esmolol administration)
Peak measurement of global LV systolic longitudinal strain
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Estimated with 3D echocardiography (Both: convectional and with esmolol administration)
Ejection Intraventricular Pressure Difference (EIVPD) measure
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Estimated with M-mode echocardiography (Both: convectional and with esmolol administration)
9 secondary outcomes
Ejection fraction
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Interleukin (IL)-1β
Time frame: At Baseline (Day 1) until Month-24 according to cohort
High-sensitivity IL-6 (hsIL-6)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Soluble Suppression of Tumorigenicity 2 (ST-2)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
N-terminal fragment of brain natriuretic peptide (NT-proBNP)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Ultrasensitive troponin I (hsTnI)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Procollagen type I terminal propeptide (PICP)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
C-terminal telopeptide collagen type I (CITP)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Matrix metalloproteinase-1 (MMP-1)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
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 1 Oct 2024.
- Background: PubMed 24173273Yotti R, Bermejo J, Benito Y, Sanz-Ruiz R, Ripoll C, Martinez-Legazpi P, del Villar CP, Elizaga J, Gonzalez-Mansilla A, Barrio A, Banares R, Fernandez-Aviles F. Validation of noninvasive indices of global systolic function in patients with normal and abnormal loading conditions: a simultaneous echocardiography pressure-volume catheterization study. Circ Cardiovasc Imaging. 2014 Jan;7(1):164-72. doi: 10.1161/CIRCIMAGING.113.000722. Epub 2013 Oct 30.
- Background: PubMed 16172285Yotti R, Bermejo J, Desco MM, Antoranz JC, Rojo-Alvarez JL, Cortina C, Allue C, Rodriguez-Abella H, Moreno M, Garcia-Fernandez MA. Doppler-derived ejection intraventricular pressure gradients provide a reliable assessment of left ventricular systolic chamber function. Circulation. 2005 Sep 20;112(12):1771-9. doi: 10.1161/CIRCULATIONAHA.104.485128.
- Background: PubMed 28195341Yotti R, Ripoll C, Benito Y, Catalina MV, Elizaga J, Rincon D, Fernandez-Aviles F, Bermejo J, Banares R. Left ventricular systolic function is associated with sympathetic nervous activity and markers of inflammation in cirrhosis. Hepatology. 2017 Jun;65(6):2019-2030. doi: 10.1002/hep.29104. Epub 2017 Apr 28.
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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.
Javier Bermejo Thomas, MD, PhD principal investigator
Hospital Universitario Gregorio Marañón
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esmolol Injection [Brevibloc] in people with Cirrhosis and Diabetes Mellitus, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 6 sites in Spain.
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 15 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
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 Tania Luis García, BS (+34 917996034 ext. 47304, tanialuisgarcia@cibercv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricle (LV) ejection fraction (time frame: At Baseline (Day 1) until Month-24 according to cohort). The study lists 3 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 NCT05769868, which also lists 3 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 1 Oct 2024.