LipoproteinemiaLOLIDANCT05181969
Long-term Characterization of Lipoprotein Apheresis Technologies for Individual Device Adaption (LOLIDA)
An observational study of Lipoproteinemia and Apheresis Related Complication, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Lipoprotein apheresis is often applied as the final treatment of patient with severe and medication resistant dyslipidemia and progressive atherosclerosis. The high effectiveness of lipoprotein apheresis to improve the patient's metabolic situation and thereby strongly minimize the incidence of cardiovascular events… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lipoproteinemia, Apheresis Related Complication, Cardiovascular Diseases
- What is being tested?
- Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV), Lipid filtration (Octo Nova®, Diamed Medizintechnik) and Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2014to 31 Dec 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undegoing lipoprotein apheresis based on the above described inclusion and exclusion criteria
Who may be able to join
- Inclusion criteria for lipoprotein apheresis in accordance with regulations of the German Federal Joint Committee of physicians and medical insurance companies (G-BA; Gemeinsamer Bundesausschuss der Ärzte und Krankenkassen) are either:
- homozygous familial hypercholesterolemia or
- severe hypercholesterolemia in patients after 12 month of dietary intervention and maximal lipid-lowering drug therapy with regard on the overall risk profile of the patient or
- Lp(a) levels > 120 nmol/L in patients with progressive cardiovascular disease after unsuccessful intervention with established methods of treatment
- Mandatory for inclusion of patients for lipoprotein apheresis is a comprehensive cardiological, angiological and lipidological pre-examination.
- (Deutsches Ärzteblatt 100 (2003), 1595; Deutsches Ärzteblatt 105 (2008), 1778)
Who cannot join
- Patients after transplantation
- Immunosuppressive therapy (including intake of glucocorticoids within four weeks prior to sample collection)
- uncontrolled arterial hypertension (>180/110 mm Hg)
- epilepsy
- acute malignant and infectious diseases
- liver disease (gamma-GT > 1.8 μmol/L×s, ALAT > 1.5 μmol/L×s),
Show all 10Show fewer
- severe renal dysfunction (GFR < 30 ml/min per 1.73 m2)
- smoking
- hypersensitivity against heparin
- participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Carl Gustav Carus University Hospital Dresden, Technische Universität Dresden,
Dresden, 01307
Marko Käppler, +49 351 458 ext. 18623, marko.kaeppler@uniklinikum-dresden.de
Jürgen Gräßler, MD
About this study
Lipoprotein apheresis is often applied as the final treatment of patient with severe and medication resistant dyslipidemia and progressive atherosclerosis. The high effectiveness of lipoprotein apheresis to improve the patient's metabolic situation and thereby strongly minimize the incidence of cardiovascular events was confirmed by a variety of studies.
While in the past years, mostly patients with severe homo- or heterozygous familial hypercholesterolemia (FH) or otherwise highly elevated LDL-cholesterol were subjected to lipoprotein apheresis, currently the major indication for lipoprotein apheresis is a critical elevated plasma level of lipoprotein (a) [Lp(a)] in patients with severe cardiovascular events. Even if it is now widely accepted that Lp(a) is an independent risk factor for cardiovascular diseases due to its pro-atherogenic potential, the exact molecular mechanisms by which Lp(a) contributes to the atherosclerotic process remain unclear. Despite rigorous reduction of plasma Lp(a)-levels during lipoprotein apheresis newly occurring cardiovascular events cannot prevented in all patients. Specific pleiotropic effects of apheresis technologies are supposed to be critically involved in the clinical outcome. By measurement of a wide variety of cardio-metabolic biomarkers playing a role in inflammation, endothelial dysfunction, lipid metabolism or blood pressure regulation during repeated Lp(a) lowering by various apheresis methods may allow the identification of clusters of risk factors determining clinical outcome and give the biological basement for an optimized individual lipoprotein apheresis therapy.
Read the detailed description
Aims The aim of the proposed project is the investigation of Lp(a) kinetics in patients under regular lipoprotein apheresis with regard to short- and long-term changes in diverse clinical parameter contributing to atherogenesis by applying different LA methods. The expected gain of knowledge might result in an improvement of patient stratification and the individual assignment to a well-tolerated and optimal apheresis procedure, which is essential for therapy outcome and improvement of the patient's life quality.
Specific questions Depending on the apheresis procedure, does the repeated use of lipoprotein apheresis therapy in patients with pathological high Lp(a) plasma concentration cause reproducible and stable changes in biomarkers of cardial dysfunction, inflammatory state, oxidative stress, endothelial dysfunction, and cardial fibrosis?
Is there an association between Lp(a)- and biomarker dynamics during long-term lipoprotein apheresis?
It is possible to identify high-risk cluster of biomarkers in patients with newly occurring cardio-vascular events after the onset of lipoprotein apheresis?
(I) Set up of examination cohorts and basal characterization of the patients
Set up of 4 patient cohorts of 15 individuals each who are currently treated with apheresis therapy:
- Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)
- Lipid filtration (Octo Nova®, Diamed Medizintechnik)
- Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)
- Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)
The observation period will cover 80 weekly apheresis sessions with plasma samples taken directly before, after and seven days after the first, the 20th, the 40th, the 60th and the 80th apheresis sessions. Parameters of routine clinical chemistry (see below) will be used for characterization of patients. Samples will be collected directly before and after apheresis and before subsequent apheresis throughout the entire observation period.
Carotid intima-media thickness (IMT) is a well-accepted non-invasive marker of subclinical atherosclerosis and end-organ damage. Measurement of IMT by intravascular ultrasound can be used to evaluate the effectiveness of different therapy modalities on the progression of atherosclerotic-based diseases.
(II) Basal clinical characterization
Parameters for clinical characterization: age, weight, height, body mass index, waist- and hip circumferences, waist to hip ratio, waist to height ratio, blood pressure
(III) Record of parameters of routine clinical chemistry
Total cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol, triglycerides (TG), ALAT, γ-GT, blood cell count, serum creatinine
(IV) Analysis of parameters for evaluation of cardio-metabolic risk profile
Biomarkers of cardiac dysfunction NT-proANP, NT-proBNP
Biomarkers characterizing inflammatory state and oxidative Stress CRP, MPO, AOPP, IL-6, TNF-α, GDF-15, Pentraxin-3
Biomarkers of endothelial dysfunction and atherosclerosis NT-proCNP, CD146, Lysophosphatidylcholine (LPC)
Evaluation of fibrosis markers Gal-3, sSt2, (soluble form of ST2 [IL1RL1]), Fibrinogen
Functional assay for thrombus formation Platelet function test
Data management and statistics:
The project will be supervised by an independent biometrician throughout all stages. All data will be stored in a central database. Responsible for completeness, accuracy, reliability, and validation are the applicants and the delegated biometrician. Original data in electronic form will be kept for 10 years on storage devices with backups performed every 14 days.
For statistical analysis the current version of SPSS package will be employed. Data will be analyzed by different models of multivariate and univariate analyses of variance.
Were applicable a principal component analysis will be used. Correlation analyses between clinical variables and plasma lipidome were performed using Spearman's nonparametric rank correlation coefficient Rho. For all statistical procedures a p-value of 0.05 or less will be considered significant.
Benefit and perspective The proposed project consists of aspects with direct clinical relevance as well as with fundamental importance in medical research on the field of lipoprotein apheresis. Important scientific findings are expected regarding the individual risk for the progression of atherosclerotic diseases in patients during apheresis therapy which can pave the way towards a patient-optimized appliance of apheresis technologies. In addition to individualized therapy, the expected result concerning pro-atherogenic biomarkers might further elucidate underlying processes in Lp(a) pathology.
- Being tested
- Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV), Lipid filtration (Octo Nova®, Diamed Medizintechnik), Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius), Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)
- Keywords
- Lipoprotein apheresis
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)Device
Lipoprotein apheresis Method I
Lipid filtration (Octo Nova®, Diamed Medizintechnik)Device
Lipoprotein apheresis Method II
Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)Device
Lipoprotein apheresis Method III
Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)Device
Lipoprotein apheresis Method IV
| Study group | Role | What they receive |
|---|---|---|
| Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV) | Apheresis therapy Receives: Device: Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV) | |
| Lipid filtration (Octo Nova®, Diamed Medizintechnik) | Apheresis therapy Receives: Device: Lipid filtration (Octo Nova®, Diamed Medizintechnik) | |
| Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius) | Apheresis therapy Receives: Device: Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius) | |
| Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec) | Apheresis therapy Receives: Device: Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of new biomarkers for individualized assignment of lipoprotein apheresis technology
Characterization of short- and long-term effects of repeated lipoprotein apheresis by dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV), lipid filtration (Octo Nova®, Diamed Medizintechnik), direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius), and TheraSorb™ (Miltenyi Biotec GmbH, Germany) on cardio-metabolic risk factors, including biomarkers of heart failure, inflammation, oxidative stress, endothelial dysfunction and fibrosis.
Measured: 10 years
Secondary outcomes (1)
Recordings of newly manifested cardiovascular events
Recording of newly manifested cardiovascular events:
- Ischemic or haemorrhagic stroke
- Myocardial infarction
- New manifestation of angina pectoris
- Implantation of cardiovascular stents
- Cases of death due to cardiovascular complications
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Oct 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipoproteinemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181969
- Sponsor's protocol ID
- EK403102014
- Acronym
- LOLIDA
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Characterization of Lipoprotein Apheresis Technologies for Individual Device Adaption (LOLIDA)
- ClinicalTrials.gov ID
- NCT05181969
- Acronym / sponsor ID
- LOLIDA / EK403102014
- Keywords
- Lipoprotein apheresis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2022 (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.
Lipoprotein apheresis is often applied as the final treatment of patient with severe and medication resistant dyslipidemia and progressive atherosclerosis. The high effectiveness of lipoprotein apheresis to improve the patient's metabolic situation and thereby strongly minimize the incidence of cardiovascular events was confirmed by a variety of studies.
While in the past years, mostly patients with severe homo- or heterozygous familial hypercholesterolemia (FH) or otherwise highly elevated LDL-cholesterol were subjected to lipoprotein apheresis, currently the major indication for lipoprotein apheresis is a critical elevated plasma level of lipoprotein (a) [Lp(a)] in patients with severe cardiovascular events. Even if it is now widely accepted that Lp(a) is an independent risk factor for cardiovascular diseases due to its pro-atherogenic potential, the exact molecular mechanisms by which Lp(a) contributes to the atherosclerotic process remain unclear. Despite rigorous reduction of plasma Lp(a)-levels during lipoprotein apheresis newly occurring cardiovascular events cannot prevented in all patients. Specific pleiotropic effects of apheresis technologies are supposed to be critically involved in the clinical outcome. By measurement of a wide variety of cardio-metabolic biomarkers playing a role in inflammation, endothelial dysfunction, lipid metabolism or blood pressure regulation during repeated Lp(a) lowering by various apheresis methods may allow the identification of clusters of risk factors determining clinical outcome and give the biological basement for an optimized individual lipoprotein apheresis therapy.
Detailed description
Aims The aim of the proposed project is the investigation of Lp(a) kinetics in patients under regular lipoprotein apheresis with regard to short- and long-term changes in diverse clinical parameter contributing to atherogenesis by applying different LA methods. The expected gain of knowledge might result in an improvement of patient stratification and the individual assignment to a well-tolerated and optimal apheresis procedure, which is essential for therapy outcome and improvement of the patient's life quality.
Specific questions Depending on the apheresis procedure, does the repeated use of lipoprotein apheresis therapy in patients with pathological high Lp(a) plasma concentration cause reproducible and stable changes in biomarkers of cardial dysfunction, inflammatory state, oxidative stress, endothelial dysfunction, and cardial fibrosis?
Is there an association between Lp(a)- and biomarker dynamics during long-term lipoprotein apheresis?
It is possible to identify high-risk cluster of biomarkers in patients with newly occurring cardio-vascular events after the onset of lipoprotein apheresis?
(I) Set up of examination cohorts and basal characterization of the patients
Set up of 4 patient cohorts of 15 individuals each who are currently treated with apheresis therapy:
- Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)
- Lipid filtration (Octo Nova®, Diamed Medizintechnik)
- Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)
- Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)
The observation period will cover 80 weekly apheresis sessions with plasma samples taken directly before, after and seven days after the first, the 20th, the 40th, the 60th and the 80th apheresis sessions. Parameters of routine clinical chemistry (see below) will be used for characterization of patients. Samples will be collected directly before and after apheresis and before subsequent apheresis throughout the entire observation period.
Carotid intima-media thickness (IMT) is a well-accepted non-invasive marker of subclinical atherosclerosis and end-organ damage. Measurement of IMT by intravascular ultrasound can be used to evaluate the effectiveness of different therapy modalities on the progression of atherosclerotic-based diseases.
(II) Basal clinical characterization
Parameters for clinical characterization: age, weight, height, body mass index, waist- and hip circumferences, waist to hip ratio, waist to height ratio, blood pressure
(III) Record of parameters of routine clinical chemistry
Total cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol, triglycerides (TG), ALAT, γ-GT, blood cell count, serum creatinine
(IV) Analysis of parameters for evaluation of cardio-metabolic risk profile
Biomarkers of cardiac dysfunction NT-proANP, NT-proBNP
Biomarkers characterizing inflammatory state and oxidative Stress CRP, MPO, AOPP, IL-6, TNF-α, GDF-15, Pentraxin-3
Biomarkers of endothelial dysfunction and atherosclerosis NT-proCNP, CD146, Lysophosphatidylcholine (LPC)
Evaluation of fibrosis markers Gal-3, sSt2, (soluble form of ST2 [IL1RL1]), Fibrinogen
Functional assay for thrombus formation Platelet function test
Data management and statistics:
The project will be supervised by an independent biometrician throughout all stages. All data will be stored in a central database. Responsible for completeness, accuracy, reliability, and validation are the applicants and the delegated biometrician. Original data in electronic form will be kept for 10 years on storage devices with backups performed every 14 days.
For statistical analysis the current version of SPSS package will be employed. Data will be analyzed by different models of multivariate and univariate analyses of variance.
Were applicable a principal component analysis will be used. Correlation analyses between clinical variables and plasma lipidome were performed using Spearman's nonparametric rank correlation coefficient Rho. For all statistical procedures a p-value of 0.05 or less will be considered significant.
Benefit and perspective The proposed project consists of aspects with direct clinical relevance as well as with fundamental importance in medical research on the field of lipoprotein apheresis. Important scientific findings are expected regarding the individual risk for the progression of atherosclerotic diseases in patients during apheresis therapy which can pave the way towards a patient-optimized appliance of apheresis technologies. In addition to individualized therapy, the expected result concerning pro-atherogenic biomarkers might further elucidate underlying processes in Lp(a) pathology.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV) | – | Device: Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)Apheresis therapy |
| Lipid filtration (Octo Nova®, Diamed Medizintechnik) | – | Device: Lipid filtration (Octo Nova®, Diamed Medizintechnik)Apheresis therapy |
| Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius) | – | Device: Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)Apheresis therapy |
| Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec) | – | Device: Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)Apheresis therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undegoing lipoprotein apheresis based on the above described inclusion and exclusion criteria
Key inclusion criteria (6 listed)
- Inclusion criteria for lipoprotein apheresis in accordance with regulations of the German Federal Joint Committee of physicians and medical insurance companies (G-BA; Gemeinsamer Bundesausschuss der Ärzte und Krankenkassen) are either:
- homozygous familial hypercholesterolemia or
- severe hypercholesterolemia in patients after 12 month of dietary intervention and maximal lipid-lowering drug therapy with regard on the overall risk profile of the patient or
- Lp(a) levels > 120 nmol/L in patients with progressive cardiovascular disease after unsuccessful intervention with established methods of treatment
- Mandatory for inclusion of patients for lipoprotein apheresis is a comprehensive cardiological, angiological and lipidological pre-examination.
Key exclusion criteria (10 listed)
- Patients after transplantation
- Immunosuppressive therapy (including intake of glucocorticoids within four weeks prior to sample collection)
- uncontrolled arterial hypertension (>180/110 mm Hg)
- epilepsy
- acute malignant and infectious diseases
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 |
|---|---|---|
| Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)Lipoprotein apheresis Method I | Device | Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV) |
| Lipid filtration (Octo Nova®, Diamed Medizintechnik)Lipoprotein apheresis Method II | Device | Lipid filtration (Octo Nova®, Diamed Medizintechnik) |
| Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)Lipoprotein apheresis Method III | Device | Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius) |
| Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)Lipoprotein apheresis Method IV | Device | Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec) |
Primary outcome
Identification of new biomarkers for individualized assignment of lipoprotein apheresis technology
Time frame: 10 years
Characterization of short- and long-term effects of repeated lipoprotein apheresis by dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV), lipid filtration (Octo Nova®, Diamed Medizintechnik), direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius), and TheraSorb™ (Miltenyi Biotec GmbH, Germany) on cardio-metabolic risk factors, including biomarkers of heart failure, inflammation, oxidative stress, endothelial dysfunction and fibrosis.
1 secondary outcome
Recordings of newly manifested cardiovascular events
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipoproteinemia and Apheresis Related Complication, run by Technische Universität Dresden at 1 site in Germany.
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 10 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: status not confirmed, as of the sponsor's last update on 10 Jan 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Gräßler, MD (+49351458 ext. 3691, Juergen.Graessler@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of new biomarkers for individualized assignment of lipoprotein apheresis technology (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.