Cardiac Allograft VasculopathyPhase 3EVOLVDNCT03734211
Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients
A Phase 3 study testing Evolocumab in people with Cardiac Allograft Vasculopathy, run by Lars Gullestad at 5 sites in 3 countries.
Trial summary
The main goal of this study is to evaluate the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de novo heart transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Allograft Vasculopathy
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Jun 2019to 20 May 2023
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be screened for eligibility during routine follow-up 4 - 8 weeks after heart transplantation. All of the following conditions must apply prior to administering the investigational medicinal product:
- Heart transplant recipient within the last 4 - 8 weeks.
- Age between 18 and 70 years.
- Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations.
- No contraindications to coronary angiography with intravascular ultrasound
- Estimated glomerular filtration rate > 20 ml/min/1.73 m2 as assessed by the MDRD formula.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- Decompensated liver disease (Child-Pugh class C)
- Severe renal failure, i.e. eGFR < 20 ml/min/1.73 m2 or on renal replacement therapy
- Ongoing rejections or infections
- Known sensitivity or intolerance to evolocumab or any of the excipients of Repatha®
- Prior use of PCSK9 inhibition treatment
Show all 10Show fewer
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- Participation in another clinical trial involving an investigational drug and/or follow-up within 30 days prior to enrolment.
- Pregnancy.
- Female subject who has either (1) not used at least one highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilised or postmenopausal.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Denmark2 sites
Department of Cardiology, Rigshospitalet
Copenhagen, 2100
Department of Cardiology, Aarhus University Hospital
Skejby, 8200
Sweden2 sites
Department of Cardiology, Sahlgrenska University Hospital
Gothenburg, SE-41345
The Clinic for Heart Failure and Valvular Disease, Skåne University Hospital and Lund University
Lund, 22185
Finland1 site
Helsinki University Hospital Heart and Lung Center
Helsinki, 00029
About this study
Official title: EVOLVD: Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients
The main goal of this study is to evaluate the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de novo heart transplant recipients.
Secondary objectives are to assess the impact of treatment on: i) cholesterol levels, ii) renal function, iii) inflammation, iv) quality of life, v) cardiac function as assessed by biomarkers and echocardiography, vi) the number of rejections, and (vii) safety and tolerability. As an exploratory outcome, the investigators will asses the effect of treatment on clinical events (death, myocardial infarction, cerebral stroke, cancer, end stage renal disease).
Read the detailed description
Cardiac allograft vasculopathy is an important cause of morbidity and mortality in heart transplant recipients. Previous data show that, although clinical coronary artery disease often manifests years after heart transplantation, there are substantial changes in the coronary artery intima thickness over the first year after transplantation, suggesting that the adverse process starts shortly after transplantation. Moreover, the investigator's previous data have suggested that, whereas early intervention can prevent the long-term progression of cardiac allograft vasculopathy, the same intervention is less effective when administered late after heart transplantation. Thus, there seems to be a window of opportunity for preventive measures against cardiac allograft vasculopathy in de-novo transplant recipients.
The strong association between cholesterol levels and coronary heart disease in the general population, the high cholesterol levels in heart transplant recipients, the high prevalence of vasculopathy in the cardiac allograft, and the association between cholesterol levels and cardiac allograft vasculopathy together provide a strong rationale for aggressive cholesterol lowering in heart transplant recipients. Statins improve outcomes in heart transplant recipients, but their limited effect on post-transplant cholesterol levels, adverse effects, and drug interactions contribute to their not providing sufficient prophylaxis against post-transplant atherosclerotic disease.
Evolocumab is a well-tested drug with a favourable safety profile. It effectively reduces cholesterol levels on top of statin therapy in patients with coronary heart disease. The investigators hypothesise that evolocumab on top of statin therapy will significantly lower low density lipoprotein (LDL) levels in de novo heart transplant recipients. The investigators assume that this reduction in cholesterol levels will manifest as a reduced burden of cardiac allograft vasculopathy as measured by intracoronary ultrasound. Ultimately, the investigators believe that a reduced burden of vasculopathy will translate to reduced morbidity and long-term mortality in heart transplant recipients. The EVOLVD trial is a randomised, placebo-controlled, double-blind study designed to test the hypothesis that treatment with evolocumab can ameliorate cardiac allograft vasculopathy in heart transplant recipients.
- Conditions
- Cardiac Allograft Vasculopathy
- Being tested
- Evolocumab, Placebo
- Keywords
- Evolocumab, Heart Transplantation, Vasculopathy
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called Repatha
420 mg evolocumab will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
PlaceboDrug
Placebo will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab | Experimental | Evolocumab (Repatha®) will be administered subcutaneously once monthly in the abdomen, thigh, or upper arm for the duration of the treatment period (one year). The 420 mg evolocumab/placebo will be administered by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector. Receives: Drug: Evolocumab |
| Placebo | Placebo comparator | The placebo is presented in an identical prefilled autoinjector. It is supplied as a sterile, single-use, preservative-free solution for subcutaneous injection in a disposable, spring-based prefilled autoinjector. The prefilled autoinjector contains a 1.0 mL deliverable volume of 1.1% (w/v) sodium carboxymethylcellulose, 250 mM proline, 10 mM acetate, and 0.01% (w/v) polysorbate 80, pH 5.0. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal intimal thickness
The maximal intimal thickness will be measured by coronary intravascular ultrasound at 12 months after randomization. The maximal intima thickness is defined as the largest distance (in mm) from the intimal leading edge to the external elastic membrane.
Measured: 12 months
Secondary outcomes (13)
Cardiac allograft vasculopathy
Incidence of cardiac allograft vasculopathy, defined as mean a maximal intimal thickness ≥0.5 mm over the entire matched segment, will be measured by intravascular ultrasound 12 months after randomization.
Measured: 12 months
Total atheroma volume
The total atheroma volume will be measured by intravascular ultrasound.
Measured: 12 months
The index of microvascular resistance
The index of microcirculatory resistance will be obtained at the time of routine coronary angiography after heart transplantation at baseline (4-10 weeks) and at the end of treatment 12 months after randomization.
Measured: 12 months
Low-density lipoprotein (LDL) cholesterol
Blood lipids must be assessed after end-of treatment only, to avoid what will effectively amount to study drug allocation unblinding. To avoid bias, the investigators will be blinded to the lipid analyses.
Measured: 12 months
Estimated glomerular filtration rate (eGFR)
The glomerular filtration rate (in in ml/min/1.73 m2) will be estimated by the MDRD formula: 175 x (SCr)-1.154 x (age)-0.203 x 0.742 [if female] x 1.212 [if black], where SCr is serum creatinine in mg/dl, and age is measured in years.
Measured: 12 months
The 36-item short form health survey questionnaire (SF-36)
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health.
Measured: 12 months
The 3-level version of EQ-5D (EQ-5D-3L) questionnaire
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Measured: 12 months
The Beck Depression Inventory (BDI)
The BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: 12 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
NT-proBNP values will be used for endpoint analyses.
Measured: 12 months
Cardiac troponin T (TnT)
Troponin T-values will be used for endpoint analyses.
Measured: 12 months
Number of rejections
Number of all rejections will be recorded through the duration of the study.
Measured: 12 months
Number of adverse events (AE)
The standard time period for collecting and recording AE and SAEs will begin at the start of study treatment and will continue for 30 day after end-of treatment (at which time approximately 30 days will have passed since the last study drug injection.
Measured: 12 months
Number of major clinical adverse events
The number of major clinical adverse events, defined as death, myocardial infarction, percutaneous coronary intervention/coronary bypass surgery, cerebral stroke, cancer, end stage renal disease (exploratory endpoint).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start10 Jun 2019
- Primary completion20 May 2023
- Study completion20 May 2023
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 Cardiac Allograft VasculopathyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Gullestad
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Skane University Hospital, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Helsinki University Central Hospital
- Responsible party
- Sponsor-investigator, Lars Gullestad, Oslo University Hospital
- Investigators
- Lars Gullestad, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734211
- Sponsor's protocol ID
- 2017-005097-19
- Other IDs
- 2017
- Acronym
- EVOLVD
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2018
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karim SR, Jensen NM, Holck EN, Clemmesen TS, Christiansen EH, Jakobsen L, Chen Z, Sonka M, Karason K, Broch K, Solberg OG, Eiskjaer H. Impact of evolocumab on coronary physiology and microstructure in de-novo heart transplant recipients. J Heart Lung Transplant. 2026 Jan;45(1):26-36. doi: 10.1016/j.healun.2025.07.037. Epub 2025 Aug 20.
PubMed 40846112Broch K, Lemstrom KB, Gustafsson F, Eiskjaer H, Karason K, Gjesdal G, Fagerland MW, Pentikainen M, Lommi J, Gude E, Andreassen AK, Clemmensen TS, Christiansen EH, Bjorkelund E, Berg ES, Arora S, Gullestad L. Randomized Trial of Cholesterol Lowering With Evolocumab for Cardiac Allograft Vasculopathy in Heart Transplant Recipients. JACC Heart Fail. 2024 Oct;12(10):1677-1688. doi: 10.1016/j.jchf.2024.04.026. Epub 2024 Jun 26.
PubMed 38934968Broch K, Gude E, Karason K, Dellgren G, Radegran G, Gjesdal G, Gustafsson F, Eiskjaer H, Lommi J, Pentikainen M, Lemstrom KB, Andreassen AK, Gullestad L. Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients: Design of the randomized controlled EVOLVD trial. Clin Transplant. 2020 Sep;34(9):e13984. doi: 10.1111/ctr.13984. Epub 2020 Aug 6.
PubMed 32445429
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVOLVD: Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT03734211
- Acronym / sponsor ID
- EVOLVD / 2017-005097-19
- Conditions
- Cardiac Allograft Vasculopathy
- Keywords
- Evolocumab, Heart Transplantation, Vasculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Lars GullestadUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Skane University Hospital, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Helsinki University Central Hospital
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 7 Nov 2018 (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 main goal of this study is to evaluate the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de novo heart transplant recipients.
Secondary objectives are to assess the impact of treatment on: i) cholesterol levels, ii) renal function, iii) inflammation, iv) quality of life, v) cardiac function as assessed by biomarkers and echocardiography, vi) the number of rejections, and (vii) safety and tolerability. As an exploratory outcome, the investigators will asses the effect of treatment on clinical events (death, myocardial infarction, cerebral stroke, cancer, end stage renal disease).
Detailed description
Cardiac allograft vasculopathy is an important cause of morbidity and mortality in heart transplant recipients. Previous data show that, although clinical coronary artery disease often manifests years after heart transplantation, there are substantial changes in the coronary artery intima thickness over the first year after transplantation, suggesting that the adverse process starts shortly after transplantation. Moreover, the investigator's previous data have suggested that, whereas early intervention can prevent the long-term progression of cardiac allograft vasculopathy, the same intervention is less effective when administered late after heart transplantation. Thus, there seems to be a window of opportunity for preventive measures against cardiac allograft vasculopathy in de-novo transplant recipients.
The strong association between cholesterol levels and coronary heart disease in the general population, the high cholesterol levels in heart transplant recipients, the high prevalence of vasculopathy in the cardiac allograft, and the association between cholesterol levels and cardiac allograft vasculopathy together provide a strong rationale for aggressive cholesterol lowering in heart transplant recipients. Statins improve outcomes in heart transplant recipients, but their limited effect on post-transplant cholesterol levels, adverse effects, and drug interactions contribute to their not providing sufficient prophylaxis against post-transplant atherosclerotic disease.
Evolocumab is a well-tested drug with a favourable safety profile. It effectively reduces cholesterol levels on top of statin therapy in patients with coronary heart disease. The investigators hypothesise that evolocumab on top of statin therapy will significantly lower low density lipoprotein (LDL) levels in de novo heart transplant recipients. The investigators assume that this reduction in cholesterol levels will manifest as a reduced burden of cardiac allograft vasculopathy as measured by intracoronary ultrasound. Ultimately, the investigators believe that a reduced burden of vasculopathy will translate to reduced morbidity and long-term mortality in heart transplant recipients. The EVOLVD trial is a randomised, placebo-controlled, double-blind study designed to test the hypothesis that treatment with evolocumab can ameliorate cardiac allograft vasculopathy in heart transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolocumab | Experimental | Drug: EvolocumabEvolocumab (Repatha®) will be administered subcutaneously once monthly in the abdomen, thigh, or upper arm for the duration of the treatment period (one year). The 420 mg evolocumab/placebo will be administered by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo is presented in an identical prefilled autoinjector. It is supplied as a sterile, single-use, preservative-free solution for subcutaneous injection in a disposable, spring-based prefilled autoinjector. The prefilled autoinjector contains a 1.0 mL deliverable volume of 1.1% (w/v) sodium carboxymethylcellulose, 250 mM proline, 10 mM acetate, and 0.01% (w/v) polysorbate 80, pH 5.0. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be screened for eligibility during routine follow-up 4 - 8 weeks after heart transplantation. All of the following conditions must apply prior to administering the investigational medicinal product:
- Heart transplant recipient within the last 4 - 8 weeks.
- Age between 18 and 70 years.
- Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations.
- No contraindications to coronary angiography with intravascular ultrasound
Key exclusion criteria (10 listed)
- Decompensated liver disease (Child-Pugh class C)
- Severe renal failure, i.e. eGFR < 20 ml/min/1.73 m2 or on renal replacement therapy
- Ongoing rejections or infections
- Known sensitivity or intolerance to evolocumab or any of the excipients of Repatha®
- Prior use of PCSK9 inhibition treatment
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 |
|---|---|---|
| EvolocumabAlso: Repatha420 mg evolocumab will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector. | Drug | Evolocumab |
| PlaceboPlacebo will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector. | Drug | Placebo |
Primary outcome
Maximal intimal thickness
Time frame: 12 months
The maximal intimal thickness will be measured by coronary intravascular ultrasound at 12 months after randomization. The maximal intima thickness is defined as the largest distance (in mm) from the intimal leading edge to the external elastic membrane.
13 secondary outcomes
Cardiac allograft vasculopathy
Time frame: 12 months
Total atheroma volume
Time frame: 12 months
The index of microvascular resistance
Time frame: 12 months
Low-density lipoprotein (LDL) cholesterol
Time frame: 12 months
Estimated glomerular filtration rate (eGFR)
Time frame: 12 months
The 36-item short form health survey questionnaire (SF-36)
Time frame: 12 months
The 3-level version of EQ-5D (EQ-5D-3L) questionnaire
Time frame: 12 months
The Beck Depression Inventory (BDI)
Time frame: 12 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: 12 months
Cardiac troponin T (TnT)
Time frame: 12 months
Number of rejections
Time frame: 12 months
Number of adverse events (AE)
Time frame: 12 months
Number of major clinical adverse events
Time frame: 12 months
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 1 Nov 2023.
- Derived from this study: PubMed 40846112Karim SR, Jensen NM, Holck EN, Clemmesen TS, Christiansen EH, Jakobsen L, Chen Z, Sonka M, Karason K, Broch K, Solberg OG, Eiskjaer H. Impact of evolocumab on coronary physiology and microstructure in de-novo heart transplant recipients. J Heart Lung Transplant. 2026 Jan;45(1):26-36. doi: 10.1016/j.healun.2025.07.037. Epub 2025 Aug 20.
- Derived from this study: PubMed 38934968Broch K, Lemstrom KB, Gustafsson F, Eiskjaer H, Karason K, Gjesdal G, Fagerland MW, Pentikainen M, Lommi J, Gude E, Andreassen AK, Clemmensen TS, Christiansen EH, Bjorkelund E, Berg ES, Arora S, Gullestad L. Randomized Trial of Cholesterol Lowering With Evolocumab for Cardiac Allograft Vasculopathy in Heart Transplant Recipients. JACC Heart Fail. 2024 Oct;12(10):1677-1688. doi: 10.1016/j.jchf.2024.04.026. Epub 2024 Jun 26.
- Derived from this study: PubMed 32445429Broch K, Gude E, Karason K, Dellgren G, Radegran G, Gjesdal G, Gustafsson F, Eiskjaer H, Lommi J, Pentikainen M, Lemstrom KB, Andreassen AK, Gullestad L. Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients: Design of the randomized controlled EVOLVD trial. Clin Transplant. 2020 Sep;34(9):e13984. doi: 10.1111/ctr.13984. Epub 2020 Aug 6.
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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.
Lars Gullestad, MD, PhD principal investigator
Oslo University Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evolocumab in people with Cardiac Allograft Vasculopathy, run by Lars Gullestad at 5 sites in 3 countries.
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: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Maximal intimal thickness (time frame: 12 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 NCT03734211, 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 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.