Refractory AnginaPhase 2EXACT2NCT07048808
Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
A Phase 2 study testing XC001 in people with Refractory Angina and Coronary Artery Disease, run by XyloCor Therapeutics, Inc. at 14 sites in United States.
Trial summary
This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Refractory Angina, Coronary Artery Disease
- What is being tested?
- XC001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 14 sitesUnited States
- Study dates
- 8 Jul 2025to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age 18 to 85 years, inclusive, at the time of signing the ICF.
- Diagnosis of chronic angina due to obstructive CAD that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) (as defined by ESC Joint Study Group on the Treatment of Refractory Angina Refractory, Mannheimer et al, EHJ 2002 and the 2013 ESC guidelines on the management of stable coronary artery disease, Montalescot et al, EHJ 2013; and Jolicoeur et al 2008).
- Angina class II-IV as measured by CCS Functional Classification of Angina Pectoris.
- History of evidence of reversible left ventricular ischemia, as assessed by stress ECG (including screening), stress echocardiography, single- photon emission computed tomography (SPECT), CT angiography imaging with fractional flow reserve analysis, stress PET (including screening) or cardiac magnetic resonance (CMR) imaging that has not resolved with intervention or by an acute coronary event.
- Coronary angiography (and/or computed tomography (coronary) angiography (CTA)) within the past 18 months unless there is a clinical indication to warrant a more current procedure as determined by the investigator.
- Two baseline ECG stress tests (treadmill test, modified Bruce protocol) that adhere to the following (details outlined in the ETT manual):
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- A modified Bruce protocol that includes two three-minute warm- up stages of 1.7 mph/ 0% grade and 1.7 mph/ 5% grade.
- TED of 90 seconds to 9.5 minutes that is limited/stopped because of angina (or angina equivalent).
- The maximally allowed variation between two subsequent treadmill tests should not exceed 25% and should not exceed 75 seconds. The ETT core laboratory must review and approve the ETTs for eligibility.
- The tests must be performed at least 48 hours apart from each other. v. A third test is permitted if the second test does not meet the criteria.
- On a stable regimen of anti-anginal, anti-hypertensive, and lipid lowering medications deemed medically appropriate for RA at the discretion of the investigator. The chronic anti-anginal regimen must include at least two functional classes at the maximally tolerated dose for the preceding 30 days prior to the screening visit (Jolicoeur 2008). Functional classes include beta-blockers, calcium channel blockers, (long-acting) nitrates, and metabolic modulators (i.e., ranolazine, trimetazidine, ivabradine, nicorandil). Use of fewer than two functional classes may be allowed if there is evidence of intolerance to those classes of anti-anginal medications.
- Formally approved by the ERC to undergo the study procedure by a review of past medical history and screening assessments, with emphasis on reversible left ventricular ischemia (further details provided in the ERC Charter).
- All subjects capable of procreation with their partners must agree to use a highly effective and medically accepted method of contraception for 6 months following the study procedure (Day 1) to avoid pregnancy (as defined in Appendix A). This is not required of female subjects who are either:
- Postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to screening. In addition, at least 2 high follicle stimulating hormone (FSH) measurements in the postmenopausal range must be used to confirm a postmenopausal state in women with less than 12 months of amenorrhea and not using hormonal contraception or hormonal replacement therapy; OR
- Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening
- Female subjects agree to not donate oocytes and male subjects must agree not to donate sperm for 6 months following administration of the investigational product (IP).
- Capable of providing informed consent and undergoing all the required tests and procedures in the protocol.
Who cannot join
- Any of the following:
- ST-Elevation or non-ST elevation myocardial infarction (STEMI or NSTEMI) not requiring revascularization, transmural MI, or cerebral vascular accident within the past 60 days prior to the screening visit.
- Uncontrolled hypercholesterolemia defined as low-density lipoprotein (LDL) above 190 mg/dL.
- Uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg, diastolic BP >100 mmHg) despite maximal medical treatment.
- Current untreated malignant ventricular arrhythmias (with episode of sustained or non-sustained ventricular tachycardia (VT) in last 30 days; suspected/probable/definite).
- Current untreated bradyarrhythmia (<50 bpm) for which a new artificial pacemaker placement is anticipated during the study period. A current pacemaker is allowed.
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- Congestive heart failure defined as New York Heart Association Function Class III or IV or left ventricular ejection fraction < 25% within the 6 weeks prior to the screening visit (or as assessed by the screening contrast Echo).
- Anginal episodes that routinely require the administration of opiates.
- Moderate to severe aortic valve stenosis (defined as Doppler echocardiography determined peak pressure gradient that exceeds 40 mm Hg (or Vmax >3.2 m/s) and/or subjects with a mechanical valve in the aorta valve position.
- Presence of a ventricular thrombus (as defined by contrast transthoracic echocardiography at screening). Subjects may be rescreened after 6 weeks of adequate treatment and absence of ventricular thrombus by echocardiography.
- Body mass index > 45 kg/m2.
- Hemoglobin < 10 g/dL, absolute neutrophil count < 1.2 × 103 per µL, platelet count < 75,000 per µL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN), total bilirubin > 2 x ULN unless the subject has a previously known history of Gilbert's syndrome and estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- Diabetic with current glycosylated hemoglobin (HbA1c) > 9.5% or active proliferative diabetic retinopathy.
- Documented active proliferative retinopathy from any cause (ETDRS [Early Treatment Diabetic Retinopathy Study] score >35).
- Uncontrolled coagulation disorder (that cannot be corrected by pharmacotherapy)
- Patients with unstable chronic obstructive pulmonary disease despite adequate treatment.
- A history or evidence of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV), or active hepatitis B virus (HBV).
- Severely immuno-compromised patients, including high-dose chronic corticosteroid therapy or cytostatic (oncolytic) therapy.
- Diagnosis of, or treatment for, any cancer within the last 5 years except for cutaneous basal or squamous cell carcinoma or carcinomas in situ where surgical excision was considered curative. (Past medical history of cancer is not exclusionary if the subject has been disease free for at least 5 years since the end of treatment).
- Known hypersensitivity or any other contraindication to adenosine, regadenoson, or contrast agents used in any of the radiographic procedures or contraindication to anesthesia employed for the study procedure.
- Pregnancy or currently lactating.
- Receiving an investigational intervention or participating in another clinical trial within 30 days or within 5 half-lives of the drug prior to screening. Exception may be made if the individual is enrolled in a non- therapeutic observational study (registry) or the observational portion of a therapeutic study where the sponsoring authority authorizes enrollment.
- Prior participation in any gene therapy; however, if the study was unblinded or documentation otherwise exists that the subject was randomized to the placebo control group and did not receive active gene transfer agent, the subject may be considered for this study. Has a serious or unstable medical or psychological condition (including drug or alcohol abuse) or other circumstance that, in the opinion of the investigator or ERC, would compromise the subject's safety or successful participation in the study or interpretation of study results. In particular, any suspected drug-seeking behavior related to chest pain should be exclusionary.
- Known allergy to nickel.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Megan McConagle, 610-402-1694, Megan.Mcgonagle@jefferson.edu
- Recruiting
Emory University
Atlanta, Georgia, 30322
Maialen Study Coordinator, 404-727-8340, modrioz@emory.edu
- Recruiting
Alabama Cardiology PC
Birmingham, Alabama, 35211
Susan Study Coordinator, 205-949-5275, sderamus@cardiologypc.com
sderamus@cardiologypc.com
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Grace Study Coordinator, 617-643-9712, agthompson@mgh.harvard.edu
- Recruiting
Christ Hospital
Cincinnati, Ohio, 45219
Brittany Study Coordinator, +1 513-585-1777, brittney.hoeffler@thechristhospital.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Shawn Study Coordinator, 216-212-2856, mcdanis4@ccf.org
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Kelsey Study Coordinator, 614-247-7133, kelsey.belski@osumc.edu
- Recruiting
Duke University
Durham, North Carolina, 27710
Hillary Study Coordinator, 919-613-6569, hillary.hood@duke.edu
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Lydia Study Coordinator, 612-863-3833, Lydia.Zenner@allina.com
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Corinne Study Coordinator, 646-962-2940, com4009@med.cornell.edu
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Monica Study Coordinator, 480-574-4272, mccarty.monica@mayo.edu
- Recruiting
Baylor Scott & White Research Institute
Plano, Texas, 75093
Andres Study Coordinator, 469.814.2000, andres.santoyo@bswhealth.org
- Not yet recruiting
Corewell Health Research Institute
Royal Oak, Michigan, 48073
Rachel Study Coordinator, 248-898-5000, Rachel.Wylie@corewellhealth.org
- Recruiting
University of Washington
Seattle, Washington, 98195
Kelly Study Coordinator, 206-543-8584, bruckk1@uw.edu
About this study
Official title: Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (With 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety
This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD.
Part 1 of the study is comprised of 3 subjects with RA (CCS class II-IV) who will receive 4×1011 viral particles (vp) XC001. An Independent Data Monitoring Committee (IDMC), the committee will review safety and feasibility data and approval to commence enrollment in Part 2 of the study.
Part 2 is a randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53). It is estimated that approximately 106 subjects will be randomized to result in 100 evaluable subjects. All subjects enrolled in Part 1, as well as Part 2 will follow all screening and safety monitoring procedures for up to 12 months (Table 2), and will be included in the safety analysis of the study.
- Conditions
- Refractory Angina, Coronary Artery Disease
- Being tested
- XC001, Sham (No Treatment)
- Keywords
- Angina, EXACT 2, Refractory angina
- Medical subject headings
- Angina Pectoris, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC001Combination product
XC001 administered by percutaneous catheter delivery using the Extroducer® Infusion Catheter System.
Sham (No Treatment)Combination product
Subjects randomized to the sham catheterization procedure group will receive the same procedure as the treatment group (with introduction of an iliofemoral or radial sheath, positioning of the pigtail catheter in the left ventricle, generation of ventriculograms, and mimicking of the injection procedure by the interventional team following a Cath Lab script), except they will not have the delivery catheter inserted and will not receive any endocardial injections
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Those randomized to the treatment group will have XC001 administered by percutaneous catheter delivery using the Extroducer® Infusion Catheter System (delivery catheter). Receives: Combination Product: XC001 |
| Sham group | Sham comparator | Subjects randomized to the sham catheterization procedure group will receive the same procedure as the treatment group (with introduction of an iliofemoral or radial sheath, positioning of the pigtail catheter in the left ventricle, generation of ventriculograms, and mimicking of the injection procedure by the interventional team following a Cath Lab script), except they will not have the delivery catheter inserted and will not receive any endocardial injections Receives: Combination Product: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
The primary objective of this study is to evaluate the effect of XC001 on a composite endpoint of a) TED from a graded treadmill test (ETT), as assessed by a core lab, b) angina frequency from a diary (extracting the 2 weeks prior to the Week 12 and Week 26 visit) and c) ischemic burden, as quantified by stress imaging by PET (as assessed by a core lab) at 12 and 26 weeks following a one-time endocardial administration to CAD patients with RA compared to the sham procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start8 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory AnginaStudies 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
- Model description
- Randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XyloCor Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Henry, MD, Principal investigator, Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048808
- Sponsor's protocol ID
- XC001-1002
- Acronym
- EXACT2
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (With 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07048808
- Acronym / sponsor ID
- EXACT2 / XC001-1002
- Conditions
- Refractory Angina, Coronary Artery Disease
- Keywords
- Angina, EXACT 2, Refractory angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- XyloCor Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD.
Part 1 of the study is comprised of 3 subjects with RA (CCS class II-IV) who will receive 4×1011 viral particles (vp) XC001. An Independent Data Monitoring Committee (IDMC), the committee will review safety and feasibility data and approval to commence enrollment in Part 2 of the study.
Part 2 is a randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53). It is estimated that approximately 106 subjects will be randomized to result in 100 evaluable subjects. All subjects enrolled in Part 1, as well as Part 2 will follow all screening and safety monitoring procedures for up to 12 months (Table 2), and will be included in the safety analysis of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53).
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Combination Product: XC001Those randomized to the treatment group will have XC001 administered by percutaneous catheter delivery using the Extroducer® Infusion Catheter System (delivery catheter). |
| Sham group | Sham comparator | Combination Product: Sham (No Treatment)Subjects randomized to the sham catheterization procedure group will receive the same procedure as the treatment group (with introduction of an iliofemoral or radial sheath, positioning of the pigtail catheter in the left ventricle, generation of ventriculograms, and mimicking of the injection procedure by the interventional team following a Cath Lab script), except they will not have the delivery catheter inserted and will not receive any endocardial injections |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females, age 18 to 85 years, inclusive, at the time of signing the ICF.
- Diagnosis of chronic angina due to obstructive CAD that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) (as defined by ESC Joint Study Group on the Treatment of Refractory Angina Refractory, Mannheimer et al, EHJ 2002 and the 2013 ESC guidelines on the management of stable coronary artery disease, Montalescot et al, EHJ 2013; and Jolicoeur et al 2008).
- Angina class II-IV as measured by CCS Functional Classification of Angina Pectoris.
- History of evidence of reversible left ventricular ischemia, as assessed by stress ECG (including screening), stress echocardiography, single- photon emission computed tomography (SPECT), CT angiography imaging with fractional flow reserve analysis, stress PET (including screening) or cardiac magnetic resonance (CMR) imaging that has not resolved with intervention or by an acute coronary event.
- Coronary angiography (and/or computed tomography (coronary) angiography (CTA)) within the past 18 months unless there is a clinical indication to warrant a more current procedure as determined by the investigator.
Key exclusion criteria (24 listed)
- Any of the following:
- Moderate to severe aortic valve stenosis (defined as Doppler echocardiography determined peak pressure gradient that exceeds 40 mm Hg (or Vmax >3.2 m/s) and/or subjects with a mechanical valve in the aorta valve position.
- Presence of a ventricular thrombus (as defined by contrast transthoracic echocardiography at screening). Subjects may be rescreened after 6 weeks of adequate treatment and absence of ventricular thrombus by echocardiography.
- Body mass index > 45 kg/m2.
- Hemoglobin < 10 g/dL, absolute neutrophil count < 1.2 × 103 per µL, platelet count < 75,000 per µL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN), total bilirubin > 2 x ULN unless the subject has a previously known history of Gilbert's syndrome and estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
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 |
|---|---|---|
| XC001XC001 administered by percutaneous catheter delivery using the Extroducer® Infusion Catheter System. | Combination product | Treatment group |
| Sham (No Treatment)Subjects randomized to the sham catheterization procedure group will receive the same procedure as the treatment group (with introduction of an iliofemoral or radial sheath, positioning of the pigtail catheter in the left ventricle, generation of ventriculograms, and mimicking of the injection procedure by the interventional team following a Cath Lab script), except they will not have the delivery catheter inserted and will not receive any endocardial injections | Combination product | Sham group |
Primary outcome
Composite endpoint
Time frame: 6 months
The primary objective of this study is to evaluate the effect of XC001 on a composite endpoint of a) TED from a graded treadmill test (ETT), as assessed by a core lab, b) angina frequency from a diary (extracting the 2 weeks prior to the Week 12 and Week 26 visit) and c) ischemic burden, as quantified by stress imaging by PET (as assessed by a core lab) at 12 and 26 weeks following a one-time endocardial administration to CAD patients with RA compared to the sham procedure.
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 11 Sep 2026.
- 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.
Tim Henry, MD principal investigator
Christ Hospital
14 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 XC001 in people with Refractory Angina and Coronary Artery Disease, run by XyloCor Therapeutics, Inc. at 14 sites in United States.
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 17 inclusion and 24 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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 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?
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 Dawn Byrnes VP Clinical Operation, MSc. (888-290-0081, dawn.byrnes@xylocor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (time frame: 6 months). 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 11 Sep 2026.