Cardiomyopathy, DilatedPhase 2NCT04192214
The Persistence of Autoantibody Neutralisation by BC 007 in Patients With Chronic HFrEF and Autoantibodies Against the Beta1-Adrenergic Receptor
A Phase 2 study testing BC 007 in people with Cardiomyopathy, Dilated and Heart Failure, run by Berlin Cures GmbH at 3 sites in Serbia.
Trial summary
Chronic heart failure (CHF) is one of the major causes of death in Western societies. Evidence has accumulated that functionally active autoantibodies directed against the beta1 adrenergic receptor (β1 AAb) are of pathophysiological relevance for the development and progression of cardiomyopathy and associated CHF. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiomyopathy, Dilated, Heart Failure, Autoantibodies
- What is being tested?
- BC 007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSerbia
- Study dates
- 29 Mar 2019to 6 Dec 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participant ≥18 years of age, at the time of signing the informed consent.
- Participant has CHF class II III, according to the NYHA classification.
- Participant has a chronic HFrEF with a left ventricular ejection fraction (LVEF) ≤40 % during screening (as assessed by in-hospital echocardiography).
- Participant screened positive for β1 AAb by a validated functional assay.
Who cannot join
- Participant has a sustained systolic blood pressure ≥160 mmHg prior to randomisation.
- Participant has a sustained bradycardia with resting heart rate <45 beats per minute (bpm) or tachycardia with resting heart rate >100 bpm prior to randomisation.
- Participant has an untreated primary valvular disease, considered clinically significant by the Investigator.
- Participant has any condition or therapy, which would make the participant unsuitable for the study, or life expectancy less than 12 months (e.g., active malignancy).
Trial locations and contacts
3 sites in 1 country.
Serbia3 sites
Bežanijska Kosa Clinical and Hospital Centre
Belgrade, 11000
Institut za kardiovaskularne bolesti Dedinje
Belgrade, 11000
Zvezdara Clinical and Hospital Centre
Belgrade, 11000
About this study
Official title: A Two Arm Randomised, Open-label Study to Investigate the Persistence of Autoantibody Neutralisation, the Safety, and Pharmacokinetics of BC 007 in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) and Autoantibodies Directed Against the beta1 Adrenergic Receptor
Chronic heart failure (CHF) is one of the major causes of death in Western societies. Evidence has accumulated that functionally active autoantibodies directed against the beta1 adrenergic receptor (β1 AAb) are of pathophysiological relevance for the development and progression of cardiomyopathy and associated CHF. BC 007 is under development for targeted neutralisation of autoantibodies directed against G protein coupled receptors, including β1 AAb. This is an open label, three-centre, randomised phase 2a study in participants with chronic HFrEF. The study will evaluate whether BC 007 causes a persistent neutralisation of the β1 AAb demonstrated by a negative β1 AAb status up to 12 months. Participants will be randomised in a 2:1 ratio to the treatment arm (BC 007) or the control arm (untreated). Treatment is repeated once up to month 11 if the participant's β1 AAb were not neutralised after 1st dosing on day 1 or reoccur.
Read the detailed description
Primary objective is:
- To compare the efficacy of an intravenous (i.v.) infusion of BC 007 with an untreated control arm in removal of β1 AAb at month 12 in participants with chronic heart failure with reduced ejection fraction (HFrEF)
Secondary objectives are:
- To evaluate the time to recurrence of β1 AAb after a single i.v. infusion of BC 007
- To evaluate the response rate and time to recurrence of β1 AAb after a repeated single i.v. infusion of BC 007 after the first recurrence of β1 AAb
- To evaluate the safety and tolerability of BC 007 after a single and a repeated single i.v. infusion
- To determine the pharmacokinetic (PK) plasma and urine profiles of BC 007
- To investigate the PK plasma profiles of BC 007 metabolites
- To investigate the β aminoisobutyric acid (β-AIBA) plasma and urine, and uric acid serum and urine concentration as a marker for BC 007 degradation
- To investigate the spontaneous conversion of β1 AAb status from positive to negative in untreated participants (control arm)
Exploratory objective is:
- To evaluate the change of the left ventricular ejection fraction (LVEF) after a single and a repeated single i.v. infusion
- Conditions
- Cardiomyopathy, Dilated, Heart Failure, Autoantibodies
- Being tested
- BC 007
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC 007Drug
1350 mg of BC 007
| Study group | Role | What they receive |
|---|---|---|
| BC 007 | Active comparator | The treatment arm will comprise 20 randomly allocated β1-AAb positive dilative cardiomyopathy (DCM) patients. Participants will receive a continuous 75 minute infusion of 1350 mg BC 007 at day 1. The β1-AAb status will be monitored 10 days after treatment and every month. Treatment is repeated once up to month 11 if the participant's β1-AAbs were not neutralized after 1st dosing on day 1 or reoccur. Receives: Drug: BC 007 |
| Control | No intervention | The control arm will comprise 10 randomly allocated β1-AAb positive DCM patients. Participants will receive standard therapy but no intervention. The β1- AAb status will be monitored every month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of β1 AAb negative participants at month 12
Measured: 12 month
Secondary outcomes (23)
Persistence of response defined as the time from initial β1 AAb neutralisation to β1 AAb recurrence.
Measured: 12 month
Response rate defined as the percentage of β1 AAb negative participants after a second treatment and persistence of response defined as the time from subsequent β1 AAb neutralisation to β1 AAb recurrence
Measured: 12 month
Comparative conversion rate of β1 AAb from positive to negative status measured by a cardiomyocyte beat rate assay in untreated participants (control arm)
Measured: 12 month
Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: 12 month
Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-inf) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Maximum observed plasma concentration (Cmax) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Apparent terminal half-life (t1/2) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Nominal time of Cmax (tmax) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Plasma clearance (CL) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Volume of distribution during terminal phase (Vz) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Terminal elimination rate constant (λz) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Measured: 6 hour post start of infusion
Cumulative amount of unchanged drug excreted into urine (Ae)
Measured: 6 hour post start of infusion
Fraction of intravenous administered drug that is excreted unchanged in urine (fe)
Measured: 6 hour post start of infusion
Renal clearance (CLR) of BC 007
Measured: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Measured: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero to the concentration after 4 hours (AUC0-4h) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Measured: 4 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero to the concentration after 6 hours (AUC0-6h) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Measured: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-inf) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Measured: 6 hour post start of infusion
Maximum observed plasma concentration (Cmax) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Measured: 6 hour post start of infusion
Nominal time of Cmax (tmax) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Measured: 6 hour post start of infusion
Cumulative amount of β-aminoisobutyric acid and uric acid excreted into urine (Ae)
Measured: 6 hour post start of infusion
Renal clearance (CLR) of β-aminoisobutyric acid and uric acid
Measured: 6 hour post start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start29 Mar 2019
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
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 Cardiomyopathy, DilatedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin Cures GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Müller, Dr., Study director, Berlin Cures GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192214
- Sponsor's protocol ID
- SBC007C201
- Status last verified
- Mar 2023
- First submitted
- 3 Dec 2019
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haberland A, Holtzhauer M, Schlichtiger A, Bartel S, Schimke I, Muller J, Dandel M, Luppa PB, Wallukat G. Aptamer BC 007 - A broad spectrum neutralizer of pathogenic autoantibodies against G-protein-coupled receptors. Eur J Pharmacol. 2016 Oct 15;789:37-45. doi: 10.1016/j.ejphar.2016.06.061. Epub 2016 Jul 1.
PubMed 27375076Wenzel K, Schulze-Rothe S, Haberland A, Muller J, Wallukat G, Davideit H. Performance and in-house validation of a bioassay for the determination of beta1-autoantibodies found in patients with cardiomyopathy. Heliyon. 2017 Jul 31;3(7):e00362. doi: 10.1016/j.heliyon.2017.e00362. eCollection 2017 Jul.
PubMed 28795160Wallukat G, Muller J, Haberland A, Berg S, Schulz A, Freyse EJ, Vetter R, Salzsieder E, Kreutz R, Schimke I. Aptamer BC007 for neutralization of pathogenic autoantibodies directed against G-protein coupled receptors: A vision of future treatment of patients with cardiomyopathies and positivity for those autoantibodies. Atherosclerosis. 2016 Jan;244:44-7. doi: 10.1016/j.atherosclerosis.2015.11.001. Epub 2015 Nov 10.
PubMed 26584137
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Arm Randomised, Open-label Study to Investigate the Persistence of Autoantibody Neutralisation, the Safety, and Pharmacokinetics of BC 007 in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) and Autoantibodies Directed Against the beta1 Adrenergic Receptor
- ClinicalTrials.gov ID
- NCT04192214
- Acronym / sponsor ID
- SBC007C201
- Conditions
- Cardiomyopathy, Dilated, Heart Failure, Autoantibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Berlin Cures GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 10 Dec 2019 (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.
Chronic heart failure (CHF) is one of the major causes of death in Western societies. Evidence has accumulated that functionally active autoantibodies directed against the beta1 adrenergic receptor (β1 AAb) are of pathophysiological relevance for the development and progression of cardiomyopathy and associated CHF. BC 007 is under development for targeted neutralisation of autoantibodies directed against G protein coupled receptors, including β1 AAb. This is an open label, three-centre, randomised phase 2a study in participants with chronic HFrEF. The study will evaluate whether BC 007 causes a persistent neutralisation of the β1 AAb demonstrated by a negative β1 AAb status up to 12 months. Participants will be randomised in a 2:1 ratio to the treatment arm (BC 007) or the control arm (untreated). Treatment is repeated once up to month 11 if the participant's β1 AAb were not neutralised after 1st dosing on day 1 or reoccur.
Detailed description
Primary objective is:
- To compare the efficacy of an intravenous (i.v.) infusion of BC 007 with an untreated control arm in removal of β1 AAb at month 12 in participants with chronic heart failure with reduced ejection fraction (HFrEF)
Secondary objectives are:
- To evaluate the time to recurrence of β1 AAb after a single i.v. infusion of BC 007
- To evaluate the response rate and time to recurrence of β1 AAb after a repeated single i.v. infusion of BC 007 after the first recurrence of β1 AAb
- To evaluate the safety and tolerability of BC 007 after a single and a repeated single i.v. infusion
- To determine the pharmacokinetic (PK) plasma and urine profiles of BC 007
- To investigate the PK plasma profiles of BC 007 metabolites
- To investigate the β aminoisobutyric acid (β-AIBA) plasma and urine, and uric acid serum and urine concentration as a marker for BC 007 degradation
- To investigate the spontaneous conversion of β1 AAb status from positive to negative in untreated participants (control arm)
Exploratory objective is:
- To evaluate the change of the left ventricular ejection fraction (LVEF) after a single and a repeated single i.v. infusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BC 007 | Active comparator | Drug: BC 007The treatment arm will comprise 20 randomly allocated β1-AAb positive dilative cardiomyopathy (DCM) patients. Participants will receive a continuous 75 minute infusion of 1350 mg BC 007 at day 1. The β1-AAb status will be monitored 10 days after treatment and every month. Treatment is repeated once up to month 11 if the participant's β1-AAbs were not neutralized after 1st dosing on day 1 or reoccur. |
| Control | No intervention | –The control arm will comprise 10 randomly allocated β1-AAb positive DCM patients. Participants will receive standard therapy but no intervention. The β1- AAb status will be monitored every month. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participant ≥18 years of age, at the time of signing the informed consent.
- Participant has CHF class II III, according to the NYHA classification.
- Participant has a chronic HFrEF with a left ventricular ejection fraction (LVEF) ≤40 % during screening (as assessed by in-hospital echocardiography).
- Participant screened positive for β1 AAb by a validated functional assay.
Key exclusion criteria (4 listed)
- Participant has a sustained systolic blood pressure ≥160 mmHg prior to randomisation.
- Participant has a sustained bradycardia with resting heart rate <45 beats per minute (bpm) or tachycardia with resting heart rate >100 bpm prior to randomisation.
- Participant has an untreated primary valvular disease, considered clinically significant by the Investigator.
- Participant has any condition or therapy, which would make the participant unsuitable for the study, or life expectancy less than 12 months (e.g., active malignancy).
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 |
|---|---|---|
| BC 0071350 mg of BC 007 | Drug | BC 007 |
Primary outcome
Proportion of β1 AAb negative participants at month 12
Time frame: 12 month
23 secondary outcomes
Persistence of response defined as the time from initial β1 AAb neutralisation to β1 AAb recurrence.
Time frame: 12 month
Response rate defined as the percentage of β1 AAb negative participants after a second treatment and persistence of response defined as the time from subsequent β1 AAb neutralisation to β1 AAb recurrence
Time frame: 12 month
Comparative conversion rate of β1 AAb from positive to negative status measured by a cardiomyocyte beat rate assay in untreated participants (control arm)
Time frame: 12 month
Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: 12 month
Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-inf) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Maximum observed plasma concentration (Cmax) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Apparent terminal half-life (t1/2) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Nominal time of Cmax (tmax) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Plasma clearance (CL) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Volume of distribution during terminal phase (Vz) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Terminal elimination rate constant (λz) derived from BC 007 and BC 007 metabolite (N-1, N-2 and N-3) plasma concentrations
Time frame: 6 hour post start of infusion
Cumulative amount of unchanged drug excreted into urine (Ae)
Time frame: 6 hour post start of infusion
Fraction of intravenous administered drug that is excreted unchanged in urine (fe)
Time frame: 6 hour post start of infusion
Renal clearance (CLR) of BC 007
Time frame: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Time frame: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero to the concentration after 4 hours (AUC0-4h) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Time frame: 4 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero to the concentration after 6 hours (AUC0-6h) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Time frame: 6 hour post start of infusion
Area under the plasma concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-inf) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Time frame: 6 hour post start of infusion
Maximum observed plasma concentration (Cmax) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Time frame: 6 hour post start of infusion
Nominal time of Cmax (tmax) derived from β-aminoisobutyric acid and uric acid plasma concentrations
Time frame: 6 hour post start of infusion
Cumulative amount of β-aminoisobutyric acid and uric acid excreted into urine (Ae)
Time frame: 6 hour post start of infusion
Renal clearance (CLR) of β-aminoisobutyric acid and uric acid
Time frame: 6 hour post start of infusion
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 3 Apr 2023.
- Background: PubMed 27375076Haberland A, Holtzhauer M, Schlichtiger A, Bartel S, Schimke I, Muller J, Dandel M, Luppa PB, Wallukat G. Aptamer BC 007 - A broad spectrum neutralizer of pathogenic autoantibodies against G-protein-coupled receptors. Eur J Pharmacol. 2016 Oct 15;789:37-45. doi: 10.1016/j.ejphar.2016.06.061. Epub 2016 Jul 1.
- Background: PubMed 28795160Wenzel K, Schulze-Rothe S, Haberland A, Muller J, Wallukat G, Davideit H. Performance and in-house validation of a bioassay for the determination of beta1-autoantibodies found in patients with cardiomyopathy. Heliyon. 2017 Jul 31;3(7):e00362. doi: 10.1016/j.heliyon.2017.e00362. eCollection 2017 Jul.
- Background: PubMed 26584137Wallukat G, Muller J, Haberland A, Berg S, Schulz A, Freyse EJ, Vetter R, Salzsieder E, Kreutz R, Schimke I. Aptamer BC007 for neutralization of pathogenic autoantibodies directed against G-protein coupled receptors: A vision of future treatment of patients with cardiomyopathies and positivity for those autoantibodies. Atherosclerosis. 2016 Jan;244:44-7. doi: 10.1016/j.atherosclerosis.2015.11.001. Epub 2015 Nov 10.
- 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.
Johannes Müller, Dr. study director
Berlin Cures GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BC 007 in people with Cardiomyopathy, Dilated and Heart Failure, run by Berlin Cures GmbH at 3 sites in Serbia.
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 4 inclusion and 4 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Serbia. 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 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?
Proportion of β1 AAb negative participants at month 12 (time frame: 12 month). 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 NCT04192214, 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 3 Apr 2023.