Hypoxic Ischemic Encephalopathy of NewbornNCT06563687
Continuous Glucose Monitoring in HIE
A study testing Dexcom ONE+ in people with Hypoxic Ischemic Encephalopathy of Newborn and Hyperglycemia, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
Trial summary
The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia, Hypoglycemia
- What is being tested?
- Dexcom ONE+
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Aug 2024to 1 Dec 2026
- Phase
- Interventional
- 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 Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight >1.8kg
- Gestation >35 weeks
- Aged <6hours
- Moderate or severe HIE following perinatal asphyxia
Who cannot join
- Major congenital malformations
- Inborn errors of metabolism,
- Congenital infections
- Imminent death
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Simona Puzone, MD contact
Italy3 sites, 3 recruiting
- Not yet recruiting
A.O.S.G. Moscati
Avellino, 83100
Sabino Moschella, MD, sabino.moschella@aornmoscati.it
Mario Diplomatico, MD, mario.diplomatico@aornmoscati.it
- Recruiting
University of Campania Luigi Vanvitelli
Naples, 80100
- Not yet recruiting
Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli
Naples, 80131
Giovanni Chello, MD, giovanni.chello@ospedalideicolli.it
Massimiliano De Vivo, MD, massimiliano.devivo@ospedalideicolli.it
About this study
Official title: Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial
The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed: mean glucose values, glucose variability within individuals, percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges.
Randomized controlled trial recruiting neonates (Birth weight >1.8kg, Gestation>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.
Read the detailed description
Neonatal hypoglycaemia and hyperglycaemia are associated with brain injury and impaired neurodevelopment outcomes in neonates with HIE. Improving early glucose control is an important modifiable risk factor for outcomes in this population. Glycaemic monitoring is usually performed by capillary or central line sampling. However, over 30% of the episodes of abnormal glucose concentration are undetected, even with regular but intermittent sampling. CGM can allow earlier detection and prevention of exposure to extreme glucose concentrations.
Study design - This is a multicentre interventional, open-label, randomized controlled trial of CGM compared with standard clinical management (control).A total of 70 neonates (Birth weight >1.8kg, Gestation >36 weeks and aged <6hours) with moderate or severe HIE following perinatal asphyxia will be recruited within 6 hours of birth after informed parental consent. Neonates with major congenital malformations, inborn errors of metabolism, congenital infections, imminent death will be excluded.
Neonates will be randomly assigned (1:1) to receive either the intervention with real-time CGM for 72 hours or standard care using a randomization program (R package SRS: A Subject Randomization System). We will use the minimization method to control for severity and to achieve balance within recruiting centres. In all the neonates recruited Dexcom ONE+ CGM (Dexcom, San Diego, CA, USA) will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for 72 h. The CGM device will be calibrated using blood glucose values measured by point-of-care test. CGM calibrations will be performed at least twice a day. CGM data will be downloaded by using Dexcom Studio software on a dedicated computer.
In the standard care group, the CGM device will collect glucose data continuously, but the clinical team will be blinded to the data. These neonates will have their glucose control monitored and managed according to standard clinical practice using intermittently sampled blood glucose levels. In the intervention group the CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data.
Interventions to target glucose control will be guided by a protocol shared among the participating hospitals. As part of the study protocol, all the neonates will receive a continuous infusion of glucose 10% of 3-4 mg/kg/minute and total fluid intake starting at 50-60 ml/kg/day followed by titration depending on urine output, renal function, and management of glucose infusion rates.
- Being tested
- Dexcom ONE+
- Keywords
- Continuous glucose monitoring, Neonatal hypoglycemia, Neonatal hyperglycemia
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom ONE+Device
In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Unblinded CGM | Experimental | CGM data will be "unblinded", with alarms on for hypo and hyperglycemia. CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data or before any treatment. Receives: Device: Dexcom ONE+ |
| Blinded CGM | Other | CGM data will be blinded. Alarms for Hypo and hyperglycemia will be off. Glucose control will be monitored and managed according to standard clinical practice using intermittently sampled blood glucose concentrations. Receives: Device: Dexcom ONE+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
In range - time
Proportion of time that the sensor glucose values are in the target range (50 to 180 mg/dL) compared between the study groups
Measured: 72 hours after birth
Secondary outcomes (4)
Hypoglycemia
Percentage of time below 50 mg/dl
Measured: 72 hours after birth
Hyperglycemia
Percentage of time above 180 mg/dl
Measured: 72 hours after birth
Glycemic variability
Evaluation of glycemic variability
Measured: 72 hours after birth
Adverse events associated to insertion of CGM
% of infants with adverse events secondary to CGM placement or wear
Measured: up to 10 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hypoxic Ischemic Encephalopathy of NewbornStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Montaldo, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563687
- Sponsor's protocol ID
- SecondUNI84
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available when scientific manuscripts are published. Data that cannot be shared publicly (e.g. to protect patient confidentiality) will be by request only. The PI will review each request on case-by-case basis. Upon approval the data requester will be asked to sign a data sharing agreement.
Publications
Kalogeropoulou MS, Thomson L, Beardsall K. Continuous glucose monitoring during therapeutic hypothermia for hypoxic ischaemic encephalopathy: a feasibility study. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):309-315. doi: 10.1136/archdischild-2022-324593. Epub 2022 Dec 20.
PubMed 36600516Pinchefsky EF, Hahn CD, Kamino D, Chau V, Brant R, Moore AM, Tam EWY. Hyperglycemia and Glucose Variability Are Associated with Worse Brain Function and Seizures in Neonatal Encephalopathy: A Prospective Cohort Study. J Pediatr. 2019 Jun;209:23-32. doi: 10.1016/j.jpeds.2019.02.027. Epub 2019 Apr 11.
PubMed 30982528Montaldo P, Caredda E, Pugliese U, Zanfardino A, Delehaye C, Inserra E, Capozzi L, Chello G, Capristo C, Miraglia Del Giudice E, Iafusco D. Continuous glucose monitoring profile during therapeutic hypothermia in encephalopathic infants with unfavorable outcome. Pediatr Res. 2020 Aug;88(2):218-224. doi: 10.1038/s41390-020-0827-4. Epub 2020 Mar 2.
PubMed 32120381Mietzsch U, Wood TR, Wu TW, Natarajan N, Glass HC, Gonzalez FF, Mayock DE, Comstock BA, Heagerty PJ, Juul SE, Wu YW; HEAL Study Group. Early Glycemic State and Outcomes of Neonates With Hypoxic-Ischemic Encephalopathy. Pediatrics. 2023 Oct 1;152(4):e2022060965. doi: 10.1542/peds.2022-060965.
PubMed 37655394Parmentier CEJ, de Vries LS, van der Aa NE, Eijsermans MJC, Harteman JC, Lequin MH, Swanenburg de Veye HFN, Koopman-Esseboom C, Groenendaal F. Hypoglycemia in Infants with Hypoxic-Ischemic Encephalopathy Is Associated with Additional Brain Injury and Worse Neurodevelopmental Outcome. J Pediatr. 2022 Jun;245:30-38.e1. doi: 10.1016/j.jpeds.2022.01.051. Epub 2022 Feb 2.
PubMed 35120986Basu SK, Kaiser JR, Guffey D, Minard CG, Guillet R, Gunn AJ; CoolCap Study Group. Hypoglycaemia and hyperglycaemia are associated with unfavourable outcome in infants with hypoxic ischaemic encephalopathy: a post hoc analysis of the CoolCap Study. Arch Dis Child Fetal Neonatal Ed. 2016 Mar;101(2):F149-55. doi: 10.1136/archdischild-2015-308733. Epub 2015 Aug 17.
PubMed 26283669Tam EWY, Kamino D, Shatil AS, Chau V, Moore AM, Brant R, Widjaja E. Hyperglycemia associated with acute brain injury in neonatal encephalopathy. Neuroimage Clin. 2021;32:102835. doi: 10.1016/j.nicl.2021.102835. Epub 2021 Sep 28.
PubMed 34601311Puzone S, Diplomatico M, Caredda E, Maietta A, Miraglia Del Giudice E, Montaldo P. Hypoglycaemia and hyperglycaemia in neonatal encephalopathy: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):18-25. doi: 10.1136/archdischild-2023-325592.
PubMed 37316160Kamino D, Widjaja E, Brant R, Ly LG, Mamak E, Chau V, Moore AM, Williams T, Tam EWY. Severity and duration of dysglycemia and brain injury among patients with neonatal encephalopathy. EClinicalMedicine. 2023 Mar 23;58:101914. doi: 10.1016/j.eclinm.2023.101914. eCollection 2023 Apr.
PubMed 37181414
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06563687
- Acronym / sponsor ID
- SecondUNI84
- Keywords
- Continuous glucose monitoring, Neonatal hypoglycemia, Neonatal hyperglycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Aug 2024 (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 aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed: mean glucose values, glucose variability within individuals, percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges.
Randomized controlled trial recruiting neonates (Birth weight >1.8kg, Gestation>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.
Detailed description
Neonatal hypoglycaemia and hyperglycaemia are associated with brain injury and impaired neurodevelopment outcomes in neonates with HIE. Improving early glucose control is an important modifiable risk factor for outcomes in this population. Glycaemic monitoring is usually performed by capillary or central line sampling. However, over 30% of the episodes of abnormal glucose concentration are undetected, even with regular but intermittent sampling. CGM can allow earlier detection and prevention of exposure to extreme glucose concentrations.
Study design - This is a multicentre interventional, open-label, randomized controlled trial of CGM compared with standard clinical management (control).A total of 70 neonates (Birth weight >1.8kg, Gestation >36 weeks and aged <6hours) with moderate or severe HIE following perinatal asphyxia will be recruited within 6 hours of birth after informed parental consent. Neonates with major congenital malformations, inborn errors of metabolism, congenital infections, imminent death will be excluded.
Neonates will be randomly assigned (1:1) to receive either the intervention with real-time CGM for 72 hours or standard care using a randomization program (R package SRS: A Subject Randomization System). We will use the minimization method to control for severity and to achieve balance within recruiting centres. In all the neonates recruited Dexcom ONE+ CGM (Dexcom, San Diego, CA, USA) will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for 72 h. The CGM device will be calibrated using blood glucose values measured by point-of-care test. CGM calibrations will be performed at least twice a day. CGM data will be downloaded by using Dexcom Studio software on a dedicated computer.
In the standard care group, the CGM device will collect glucose data continuously, but the clinical team will be blinded to the data. These neonates will have their glucose control monitored and managed according to standard clinical practice using intermittently sampled blood glucose levels. In the intervention group the CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data.
Interventions to target glucose control will be guided by a protocol shared among the participating hospitals. As part of the study protocol, all the neonates will receive a continuous infusion of glucose 10% of 3-4 mg/kg/minute and total fluid intake starting at 50-60 ml/kg/day followed by titration depending on urine output, renal function, and management of glucose infusion rates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Unblinded CGM | Experimental | Device: Dexcom ONE+CGM data will be "unblinded", with alarms on for hypo and hyperglycemia. CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data or before any treatment. |
| Blinded CGM | Other | Device: Dexcom ONE+CGM data will be blinded. Alarms for Hypo and hyperglycemia will be off. Glucose control will be monitored and managed according to standard clinical practice using intermittently sampled blood glucose concentrations. |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight >1.8kg
- Gestation >35 weeks
- Aged <6hours
- Moderate or severe HIE following perinatal asphyxia
Key exclusion criteria (4 listed)
- Major congenital malformations
- Inborn errors of metabolism,
- Congenital infections
- Imminent death
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 |
|---|---|---|
| Dexcom ONE+In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia. | Device | Blinded CGM, Experimental: Unblinded CGM |
Primary outcome
In range - time
Time frame: 72 hours after birth
Proportion of time that the sensor glucose values are in the target range (50 to 180 mg/dL) compared between the study groups
4 secondary outcomes
Hypoglycemia
Time frame: 72 hours after birth
Hyperglycemia
Time frame: 72 hours after birth
Glycemic variability
Time frame: 72 hours after birth
Adverse events associated to insertion of CGM
Time frame: up to 10 days after birth
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 21 Aug 2024.
- Background: PubMed 36600516Kalogeropoulou MS, Thomson L, Beardsall K. Continuous glucose monitoring during therapeutic hypothermia for hypoxic ischaemic encephalopathy: a feasibility study. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):309-315. doi: 10.1136/archdischild-2022-324593. Epub 2022 Dec 20.
- Background: PubMed 30982528Pinchefsky EF, Hahn CD, Kamino D, Chau V, Brant R, Moore AM, Tam EWY. Hyperglycemia and Glucose Variability Are Associated with Worse Brain Function and Seizures in Neonatal Encephalopathy: A Prospective Cohort Study. J Pediatr. 2019 Jun;209:23-32. doi: 10.1016/j.jpeds.2019.02.027. Epub 2019 Apr 11.
- Background: PubMed 32120381Montaldo P, Caredda E, Pugliese U, Zanfardino A, Delehaye C, Inserra E, Capozzi L, Chello G, Capristo C, Miraglia Del Giudice E, Iafusco D. Continuous glucose monitoring profile during therapeutic hypothermia in encephalopathic infants with unfavorable outcome. Pediatr Res. 2020 Aug;88(2):218-224. doi: 10.1038/s41390-020-0827-4. Epub 2020 Mar 2.
- Background: PubMed 37655394Mietzsch U, Wood TR, Wu TW, Natarajan N, Glass HC, Gonzalez FF, Mayock DE, Comstock BA, Heagerty PJ, Juul SE, Wu YW; HEAL Study Group. Early Glycemic State and Outcomes of Neonates With Hypoxic-Ischemic Encephalopathy. Pediatrics. 2023 Oct 1;152(4):e2022060965. doi: 10.1542/peds.2022-060965.
- Background: PubMed 35120986Parmentier CEJ, de Vries LS, van der Aa NE, Eijsermans MJC, Harteman JC, Lequin MH, Swanenburg de Veye HFN, Koopman-Esseboom C, Groenendaal F. Hypoglycemia in Infants with Hypoxic-Ischemic Encephalopathy Is Associated with Additional Brain Injury and Worse Neurodevelopmental Outcome. J Pediatr. 2022 Jun;245:30-38.e1. doi: 10.1016/j.jpeds.2022.01.051. Epub 2022 Feb 2.
- Background: PubMed 26283669Basu SK, Kaiser JR, Guffey D, Minard CG, Guillet R, Gunn AJ; CoolCap Study Group. Hypoglycaemia and hyperglycaemia are associated with unfavourable outcome in infants with hypoxic ischaemic encephalopathy: a post hoc analysis of the CoolCap Study. Arch Dis Child Fetal Neonatal Ed. 2016 Mar;101(2):F149-55. doi: 10.1136/archdischild-2015-308733. Epub 2015 Aug 17.
- Background: PubMed 34601311Tam EWY, Kamino D, Shatil AS, Chau V, Moore AM, Brant R, Widjaja E. Hyperglycemia associated with acute brain injury in neonatal encephalopathy. Neuroimage Clin. 2021;32:102835. doi: 10.1016/j.nicl.2021.102835. Epub 2021 Sep 28.
- Background: PubMed 37316160Puzone S, Diplomatico M, Caredda E, Maietta A, Miraglia Del Giudice E, Montaldo P. Hypoglycaemia and hyperglycaemia in neonatal encephalopathy: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):18-25. doi: 10.1136/archdischild-2023-325592.
- Background: PubMed 37181414Kamino D, Widjaja E, Brant R, Ly LG, Mamak E, Chau V, Moore AM, Williams T, Tam EWY. Severity and duration of dysglycemia and brain injury among patients with neonatal encephalopathy. EClinicalMedicine. 2023 Mar 23;58:101914. doi: 10.1016/j.eclinm.2023.101914. eCollection 2023 Apr.
- Individual participant dataSharing planned: Yes. Data will be made available when scientific manuscripts are published. Data that cannot be shared publicly (e.g. to protect patient confidentiality) will be by request only. The PI will review each request on case-by-case basis. Upon approval the data requester will be asked to sign a data sharing agreement.
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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.
Simona Puzone, MD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom ONE+ in people with Hypoxic Ischemic Encephalopathy of Newborn and Hyperglycemia, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
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 Paolo Montaldo, PhD (0815664023 ext. +39, paolo.montaldo@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In range - time (time frame: 72 hours after birth). 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 NCT06563687, which also lists 9 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 21 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.