Acute Myocardial InfarctionPhase 2/3SITAGRAMINCT00650143
Sitagliptin Plus Granulocyte-colony Stimulating Factor in Acute Myocardial Infarction
A Phase 2/3 study testing Lenograstim (GRANOCYTE)=GCSF, Sitagliptin (Januvia) and Sodium Chloride (NaCl) 0.9 % in people with Acute Myocardial Infarction, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Trial design: This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing routine percutaneous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Lenograstim (GRANOCYTE)=GCSF, Sitagliptin (Januvia) and Sodium Chloride (NaCl) 0.9 %
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Jun 2013
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old, male or female
- Have acute ST segment elevation myocardial infarction (typical chest pain of more than 30 minutes duration, presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block) and/or occluded coronary artery
- Intervention of infarct related artery by PCI/Stenting within 2-24 hours after onset of acute myocardial infarction.
- have creatinin kinase elevation of more than three times of upper normal level (i.e. 540 U/l) accompanied by a significant elevation of CK-MB isoenzyme and/or Troponin I/T
- Have regional wall motion abnormality (comprising hypo-, a- or dyskinesia) of at least one myocardial segment demonstrated with MRI.
- Patients who are further suitable for coronary angiography and angioplasty with stenting of the infarct related artery.
- Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.
- Give a written informed consent.
Who cannot join
- General:
- Women of childbearing potential, pregnancy or being lactating.
- Be unable to undergo percutaneous cardiac catheterisation
- Have contraindications against magnetic resonance imaging (e.g. non-MR compatible implants or medical devices)
- Have conditions that may severely degrade image quality (e.g. severe arrhythmia) or prevents from MR scanning (e.g. claustrophobia)
- Previous enrolment in the present trial or administration of any study medication within the previous 30 days. Study drug is defined as any material (placebo or drug) dispensed under the provisions of a protocol.
Show all 32Show fewer
- Have other severe concurrent illness (e.g., active infection, malignancy).
- Life expectancy of less than one year.
- Have a history of alcohol or drug abuse within 3 months prior to admission or factors jeopardising follow-up.
- Renal, hepatic, metabolic:
- Moderate to severe renal impairment (Crea level >1.7 mg/dL or glomerular filtration rate <35 ml/min).
- Diabetes type 1 patients.
- Diabetic ketoacidosis.
- Concomitant medications known to cause hypoglycemia, such as sulfonylureas.
- Severe liver dysfunction.
- Haematologic:
- Malignant haematological diseases, i.e. chronic myeloic leukemia (CML) or myelodysplastic syndromes (MDS)
- Severe congenital neutropenia with cytogenetic abnormalities
- Known allergic reaction vs. Lenograstim
- Cardiovascular:
- Acute cardiogenic shock
- Cardiomyopathy with an ejection fraction below 0.25 (i.e. ischemic or dilated cardiomyopathy resulting in congestive heart failure)
- Infective endocarditis
- Factors contraindicating cardiac catheterisation (e.g. severe allergy against iodine, severe thyroid disease)
- Planned operative revascularisation
- Left ventricular thrombus
- Severe cardiac arrhythmias (i.e. malignant sustained or non-sustained ventricular tachycardia or ventricular fibrillation) within 24 hours after admission.
- Pulmonary:
- Acute massive pulmonary infiltrations
- History of pneumonia in the last 4 weeks
- Other:
- 1. Therapy with immunosuppressants, cytostatics, corticoids.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of the University of Munich-Grosshadern, Department of Cardiology
Munich, 81377
About this study
Official title: Safety and Efficacy of Sitagliptin Plus Granulocyte-colony Stimulating Factor in Patients Suffering From Acute Myocardial Infarction
Trial design:
This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing routine percutaneous coronary revascularisation for acute myocardial infarction (time from onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group, n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function from baseline to 6 months of follow-up.
Read the detailed description
The trial will be conducted as a multi-centre trial. Secondary objectives of this study are to monitor changes of regional myocardial function, myocardial perfusion and extent of non-viable myocardium from baseline to 6 months after revascularisation between the treatment groups. Furthermore the following parameters over up to 12 months of follow-up are analysed: occurrence of major adverse cardiac events (death, myocardial infarction, coronary bypass grafting, or re-intervention), spontaneously reported adverse events. Analyses of cardiac function consists of evaluation of segmental systolic wall thickening, end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and cardiac output by means of magnetic resonance imaging (MRI). The extent of non-viable myocardium and myocardial perfusion will be assessed using contrast enhanced MRI.
This study consists of a revascularisation period (angioplasty of the infarcted vessel), a treatment period (up to 28 days), and a follow-up period (up to 12 months). The Revascularisation Period starts with the treatment of the patient in the emergency room. As soon as possible the patient will be transferred to the catheterisation laboratory where acute percutaneous coronary intervention (PCI) of the infarct-related artery will be performed. The first phase of the Treatment Period consists of a screening period during which a patient's eligibility is preliminarily evaluated. The second phase of the Treatment Period is the randomisation for patients in the control or G-CSF/Sitagliptin treatment group. After baseline MRI, patients are randomised. Patients will be treated either with G-CSF (10µg/kg/d divided in two doses subcutaneously) over a period of 5 days and Sitagliptin 100 mg each day for 28 days or with placebo. Patients will be randomised in 1:1 ratio to the control and verum therapy treatment groups. Follow-up Period assessments will be performed in all patients at 6 months including clinical status, occurrence of adverse events, laboratory investigations, and MRI. To assess occurrence of in-stent restenosis, routine control angiography will be performed in all patients 6 months after initial PCI. Safety will be evaluated by monitoring treatment-emergent signs and symptoms, 12-lead ECGs, vital signs, physical examination, and clinical laboratory assessments after 1 month and 1 year.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Lenograstim (GRANOCYTE)=GCSF, Sitagliptin (Januvia), Sodium Chloride (NaCl) 0.9 %, Gelatin
- Keywords
- Stem cell, Myocardial infarction, G-CSF, CD26-inhibition
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenograstim (GRANOCYTE)=GCSFDrug
10 µg/kg/d s.c. for 5 days divided in two dosages per day
Sitagliptin (Januvia)Drug
100 mg p.o. per day for 28 days
Sodium Chloride (NaCl) 0.9 %Drug
applied s.c. twice a day for 5 days
GelatinDrug
One capsule p.o. per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Application G-CSF (10µg/kg/d divided in two doses subcutaneously) over a period of 5 days and Sitagliptin 100 mg each day for 28 days.
n=74 Receives: Drug: Lenograstim (GRANOCYTE)=GCSF; Drug: Sitagliptin (Januvia) |
| 2 | Placebo comparator | NaCl 0.9% applied twice daily over a period of 5 days and oral Placebo given once a day for 28 days.
n=74 Receives: Drug: Sodium Chloride (NaCl) 0.9 %; Drug: Gelatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of global myocardial function from baseline to 6 months of follow-up.
Measured: Recruitment period: 4,5 years. Follow-up assessment: 1 year. Analyses and reporting: 6 months. Overall duration: 6 years.
Secondary outcomes (8)
Segmental end-diastolic myocardial thickness, segmental systolic wall thickening, regional contractile reserve, end-diastolic and end-systolic volumes, stroke volume, and cardiac output in MRI
Measured: 6 months of follow-up
Extent of non-viable myocardium will be monitored from baseline up to 6 months measured by MRI delayed enhancement.
Measured: 6 months follow up
Change of myocardial perfusion at rest up to 6 months as measured by signal-time curve parameters using first-pass perfusion MRI
Measured: 6 month follow up
Occurrence of major adverse cardiac events (death, myocardial infarction, CABG, or re-intervention) up to 12 months.
Measured: 12 months follow up
Safety of a treatment of Sitagliptin in combination with G-CSF in CAD patients suffering from MI (spontaneously reported adverse events (AEs) up to 12 months).
Measured: 12 months follow up
Change of peripheral blood stem cell populations: CD34, CD34/KDR and CD34/CD26 positive cells prior to and 5 days after therapy initiation.
Measured: 1 week follow up
Change of plasma levels of NT-pro-BNP, glucose, complete blood count, CRP, platelets, CK, cTnI prior to and 5 and 28 days, and 6 months after therapy initiation
Measured: 12 month follow up
Assessment of in stent restenosis using angiography 6 months after facultative PCI
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Theiss, Ludwig-Maximilians - University of Munich
- Investigators
- Wolfgang M Franz, Prof. Dr., Principal investigator, Clinic of the University of Munich-Grosshadern, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650143
- Sponsor's protocol ID
- 22021980
- Acronym
- SITAGRAMI
- Status last verified
- Aug 2022
- First submitted
- 27 Mar 2008
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Engelmann MG, Theiss HD, Hennig-Theiss C, Huber A, Wintersperger BJ, Werle-Ruedinger AE, Schoenberg SO, Steinbeck G, Franz WM. Autologous bone marrow stem cell mobilization induced by granulocyte colony-stimulating factor after subacute ST-segment elevation myocardial infarction undergoing late revascularization: final results from the G-CSF-STEMI (Granulocyte Colony-Stimulating Factor ST-Segment Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2006 Oct 17;48(8):1712-21. doi: 10.1016/j.jacc.2006.07.044. Epub 2006 Sep 11.
PubMed 17045910Brenner C, Adrion C, Grabmaier U, Theisen D, von Ziegler F, Leber A, Becker A, Sohn HY, Hoffmann E, Mansmann U, Steinbeck G, Franz WM, Theiss HD. Sitagliptin plus granulocyte colony-stimulating factor in patients suffering from acute myocardial infarction: A double-blind, randomized placebo-controlled trial of efficacy and safety (SITAGRAMI trial). Int J Cardiol. 2016 Feb 15;205:23-30. doi: 10.1016/j.ijcard.2015.11.180. Epub 2015 Nov 30.
PubMed 26709136
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sitagliptin Plus Granulocyte-colony Stimulating Factor in Patients Suffering From Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00650143
- Acronym / sponsor ID
- SITAGRAMI / 22021980
- Conditions
- Acute Myocardial Infarction
- Keywords
- Stem cell, Myocardial infarction, G-CSF, CD26-inhibition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Apr 2008 (estimated)
- 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.
Trial design:
This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing routine percutaneous coronary revascularisation for acute myocardial infarction (time from onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group, n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function from baseline to 6 months of follow-up.
Detailed description
The trial will be conducted as a multi-centre trial. Secondary objectives of this study are to monitor changes of regional myocardial function, myocardial perfusion and extent of non-viable myocardium from baseline to 6 months after revascularisation between the treatment groups. Furthermore the following parameters over up to 12 months of follow-up are analysed: occurrence of major adverse cardiac events (death, myocardial infarction, coronary bypass grafting, or re-intervention), spontaneously reported adverse events. Analyses of cardiac function consists of evaluation of segmental systolic wall thickening, end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and cardiac output by means of magnetic resonance imaging (MRI). The extent of non-viable myocardium and myocardial perfusion will be assessed using contrast enhanced MRI.
This study consists of a revascularisation period (angioplasty of the infarcted vessel), a treatment period (up to 28 days), and a follow-up period (up to 12 months). The Revascularisation Period starts with the treatment of the patient in the emergency room. As soon as possible the patient will be transferred to the catheterisation laboratory where acute percutaneous coronary intervention (PCI) of the infarct-related artery will be performed. The first phase of the Treatment Period consists of a screening period during which a patient's eligibility is preliminarily evaluated. The second phase of the Treatment Period is the randomisation for patients in the control or G-CSF/Sitagliptin treatment group. After baseline MRI, patients are randomised. Patients will be treated either with G-CSF (10µg/kg/d divided in two doses subcutaneously) over a period of 5 days and Sitagliptin 100 mg each day for 28 days or with placebo. Patients will be randomised in 1:1 ratio to the control and verum therapy treatment groups. Follow-up Period assessments will be performed in all patients at 6 months including clinical status, occurrence of adverse events, laboratory investigations, and MRI. To assess occurrence of in-stent restenosis, routine control angiography will be performed in all patients 6 months after initial PCI. Safety will be evaluated by monitoring treatment-emergent signs and symptoms, 12-lead ECGs, vital signs, physical examination, and clinical laboratory assessments after 1 month and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lenograstim (GRANOCYTE)=GCSF, Drug: Sitagliptin (Januvia)Application G-CSF (10µg/kg/d divided in two doses subcutaneously) over a period of 5 days and Sitagliptin 100 mg each day for 28 days. n=74 |
| 2 | Placebo comparator | Drug: Sodium Chloride (NaCl) 0.9 %, Drug: GelatinNaCl 0.9% applied twice daily over a period of 5 days and oral Placebo given once a day for 28 days. n=74 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years old, male or female
- Have acute ST segment elevation myocardial infarction (typical chest pain of more than 30 minutes duration, presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block) and/or occluded coronary artery
- Intervention of infarct related artery by PCI/Stenting within 2-24 hours after onset of acute myocardial infarction.
- have creatinin kinase elevation of more than three times of upper normal level (i.e. 540 U/l) accompanied by a significant elevation of CK-MB isoenzyme and/or Troponin I/T
- Have regional wall motion abnormality (comprising hypo-, a- or dyskinesia) of at least one myocardial segment demonstrated with MRI.
Key exclusion criteria (32 listed)
- Women of childbearing potential, pregnancy or being lactating.
- Be unable to undergo percutaneous cardiac catheterisation
- Have contraindications against magnetic resonance imaging (e.g. non-MR compatible implants or medical devices)
- Have conditions that may severely degrade image quality (e.g. severe arrhythmia) or prevents from MR scanning (e.g. claustrophobia)
- Previous enrolment in the present trial or administration of any study medication within the previous 30 days. Study drug is defined as any material (placebo or drug) dispensed under the provisions of a protocol.
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 |
|---|---|---|
| Lenograstim (GRANOCYTE)=GCSF10 µg/kg/d s.c. for 5 days divided in two dosages per day | Drug | 1 |
| Sitagliptin (Januvia)100 mg p.o. per day for 28 days | Drug | 1 |
| Sodium Chloride (NaCl) 0.9 %applied s.c. twice a day for 5 days | Drug | 2 |
| GelatinOne capsule p.o. per day for 28 days | Drug | 2 |
Primary outcome
Change of global myocardial function from baseline to 6 months of follow-up.
Time frame: Recruitment period: 4,5 years. Follow-up assessment: 1 year. Analyses and reporting: 6 months. Overall duration: 6 years.
8 secondary outcomes
Segmental end-diastolic myocardial thickness, segmental systolic wall thickening, regional contractile reserve, end-diastolic and end-systolic volumes, stroke volume, and cardiac output in MRI
Time frame: 6 months of follow-up
Extent of non-viable myocardium will be monitored from baseline up to 6 months measured by MRI delayed enhancement.
Time frame: 6 months follow up
Change of myocardial perfusion at rest up to 6 months as measured by signal-time curve parameters using first-pass perfusion MRI
Time frame: 6 month follow up
Occurrence of major adverse cardiac events (death, myocardial infarction, CABG, or re-intervention) up to 12 months.
Time frame: 12 months follow up
Safety of a treatment of Sitagliptin in combination with G-CSF in CAD patients suffering from MI (spontaneously reported adverse events (AEs) up to 12 months).
Time frame: 12 months follow up
Change of peripheral blood stem cell populations: CD34, CD34/KDR and CD34/CD26 positive cells prior to and 5 days after therapy initiation.
Time frame: 1 week follow up
Change of plasma levels of NT-pro-BNP, glucose, complete blood count, CRP, platelets, CK, cTnI prior to and 5 and 28 days, and 6 months after therapy initiation
Time frame: 12 month follow up
Assessment of in stent restenosis using angiography 6 months after facultative PCI
Time frame: 6 month follow up
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 25 Aug 2022.
- Background: PubMed 17045910Engelmann MG, Theiss HD, Hennig-Theiss C, Huber A, Wintersperger BJ, Werle-Ruedinger AE, Schoenberg SO, Steinbeck G, Franz WM. Autologous bone marrow stem cell mobilization induced by granulocyte colony-stimulating factor after subacute ST-segment elevation myocardial infarction undergoing late revascularization: final results from the G-CSF-STEMI (Granulocyte Colony-Stimulating Factor ST-Segment Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2006 Oct 17;48(8):1712-21. doi: 10.1016/j.jacc.2006.07.044. Epub 2006 Sep 11.
- Derived from this study: PubMed 26709136Brenner C, Adrion C, Grabmaier U, Theisen D, von Ziegler F, Leber A, Becker A, Sohn HY, Hoffmann E, Mansmann U, Steinbeck G, Franz WM, Theiss HD. Sitagliptin plus granulocyte colony-stimulating factor in patients suffering from acute myocardial infarction: A double-blind, randomized placebo-controlled trial of efficacy and safety (SITAGRAMI trial). Int J Cardiol. 2016 Feb 15;205:23-30. doi: 10.1016/j.ijcard.2015.11.180. Epub 2015 Nov 30.
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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.
Wolfgang M Franz, Prof. Dr. principal investigator
Clinic of the University of Munich-Grosshadern, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lenograstim (GRANOCYTE)=GCSF, Sitagliptin (Januvia) and Sodium Chloride (NaCl) 0.9 % in people with Acute Myocardial Infarction, run by Ludwig-Maximilians - University of Munich 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 8 inclusion and 32 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 25 Aug 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. 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 combined 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.
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?
Change of global myocardial function from baseline to 6 months of follow-up. (time frame: Recruitment period: 4,5 years. Follow-up assessment: 1 year. Analyses and reporting: 6 months. Overall duration: 6 years.). 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 NCT00650143, which also lists 2 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 25 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.