Pediatric Cardiac SurgeryPhase 3PRECISENCT06626035
Evaluation of Analgesia for Cardiac Elective Surgery in Children
A Phase 3 study testing Methadone based ERAS and Non-methadone based group in people with Pediatric Cardiac Surgery, run by Senthil Sadhasivam at 3 sites in United States.
Trial summary
The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Cardiac Surgery
- What is being tested?
- Methadone based ERAS and Non-methadone based group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Dec 2025to 31 Aug 2029
- Phase
- Phase 3
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 3-years - <18 years
- ASA physical status 1, 2, or 3
- Participant or legal guardian can speak and read English or Spanish
- Undergoing the following cardiac surgeries (Categories 1 \& 2) that are associated with significant acute surgical pain
- STS Category 1:
- ASD, PFO closure
Show all 18Show fewer
- VSD repairs,
- Aortic stenosis sub-valvular repair
- ASD and Partial anomalous venous return repair
- AV canal transitional
- Conduit replacement
- Valve replacement (AVR, PVR)
- TOF repair without ventriculostomy
- STS Category 2:
- Glenn shunt (on Bypass only)
- Fontan surgery (on Bypass only)
- Pulmonary artery plasty (main)
- Left Atrium (LA) to Pulmonary Artery (PA) conduit replacement.
Who cannot join
- Pregnant patients
- Methadone allergy
- Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
- Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)
- Preoperative opioid use within 30 days before surgery
- History of severe sleep apnea (have a sleep study with an AHI index score more than 10 or clinical signs of sleep disordered breathing - snoring, daytime drowsiness)
- Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dayana Alsamsam, BSPS, MSc contact
United States3 sites, 3 recruiting
- Not yet recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Vidya Chidambaran, MD, (513) 636-4408, vidya.chidambaran@cchmc.org
Vidya Chidambaran, MD
- Not yet recruiting
UCSF Benioff Children's Hospital
Oakland, California, 94618
Anshuman Sharma, MD, (510) 428-3000, Anshuman.sharma@UCSF.edu
Anshuman Sharma, MD
- Recruiting
UPMC Children's Hospital
Pittsburgh, Pennsylvania, 15213
Senthilkumar Sadhasivam, MD, MPH, 412-647-4484, sadhasivams@upmc.edu
Alisha Maslanka, BS, 412-491-2748, maslankaaa@upmc.edu
About this study
Official title: Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)
The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Randomly assigning means that there is a 50/50 chance, like a coin flip, of being assigned to either research group.
Read the detailed description
SPECIFIC AIMS. The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Cardiac) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing, and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after cardiac surgery (CS) in children.
The long-term goal is to proactively improve the safety and efficacy of surgical pain control while reducing opioid AEs and the opioid epidemic burden in all children undergoing inpatient surgeries. The central hypothesis is that a standardized, multidose, methadone-based ERAS protocol will reduce acute surgical pain, overall opioid use, RD, PONV, and CPSP compared with standard-of-care short-acting opioid-based analgesia in children undergoing CS (Aim 1). Investigators will use PK and genetic variations along with CPB-related dilution and clinical factors to develop optimal intra- and post-operative methadone dosing in children to enable precision analgesia in the future (Aim 2). Finally, the study team will identify patient profiles with genetic, epigenetic, PK, clinical, and psychological factors to predict benefit from assigned analgesia for optimal clinical outcomes (Aim 3). The expert multidisciplinary and multicenter team will enroll a total of 1000 children to conduct two parallel randomized clinical trials for CS (500 children 1 month-18 yrs from 5 clinical sites). In this study, specifically, Investigators will:
Aim 1. Conduct a randomized trial in CS to compare acute pain relief, opioid-sparing efficacy, and safety of standardized perioperative multidose methadone-based ERAS vs. standard-of-care non-methadone-based analgesia. Acute surgical pain, opioid needs (morphine equivalents), RD, PONV, and CPSP will be lower in methadone-based analgesia compared to short-acting opioid-based analgesia.
Aim 2. Develop precision methadone dosing based on age, CYP2B6 and ORM1 variants, AAG, and CPB. Age, CYP2B6 and ORM1 variants, AAG levels, and CPB-related dilution will explain methadone's PK variability and dose adjustments that correlate with optimal clinical outcomes among 500 children receiving methadone.
Aim 3. Identify patient profiles that predict benefits from the assigned analgesia protocol to optimize clinical outcomes. Personalized risk prediction models will be developed and validated including genetic variants (i.e., CYP2B6, CYP2D6, ABCB1, OPRM1, and FAAH), and psychological and clinical factors to predict benefit with the assigned treatments (methadone or non-methadone) for pre-specified clinical endpoints (i.e., lower acute surgical pain, RD, PONV, OD, and CPSP).
Overall Impact: The study team will develop actionable evidence for the efficacy of standardized, multidose, methadone-based ERAS protocols and will harness genetic, clinical, and psychological factors contributing to variability in methadone and oxycodone PK, acute surgical pain, transition to CPSP, opioid-induced PONV, RD, and dependence to develop personalized analgesia strategy and dosing for children undergoing CS. Implementation of evidence-based standardized methadone-based ERAS pain management and individualized risk prediction will maximize acute surgical pain relief while minimizing opioid use and AEs in millions of children.
- Conditions
- Pediatric Cardiac Surgery
- Being tested
- Methadone based ERAS, Non-methadone based group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone based ERASDrug
Also called Methadone-Based
Children randomized to the methadone arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
Non-methadone based groupDrug
Also called Standard Care
Children randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.
| Study group | Role | What they receive |
|---|---|---|
| Methadone-Based ERAS Group | Experimental | The methadone-based standardized analgesia intervention arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting. Receives: Drug: Methadone based ERAS |
| Non-Methadone-Based Group | Active comparator | Children randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. Receives: Drug: Non-methadone based group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average postoperative pain scores
Average postoperative pain scores within 48 hours of surgery (Numerical Rating Scale [NRS], or Facial expression, Leg movement, Activity, Cry, and Consolability [FLACC], both 0-10). Outcome will be reported based on area under the curve (AUC) as mean(SD).
Measured: Postoperative 48 hours
Total postoperative opioid use
Total Opioid use in Morphine Milligram Equivalents (MME), will be reported as mean (SD).
Measured: Postoperative 48 hours
Secondary outcomes (8)
Incidence of Inpatient Respiratory Depression (RD)
RD is defined as respiratory rate <8 breaths per minute requiring oxygen in the absence of airway obstruction.
Measured: Postoperative 120-hours
Incidence of Inpatient Postoperative Nausea and Vomiting (PONV)
PONV will be assessed by self-report, EMR, and medication use. Outcome measure will be reported as n(%).
Measured: Postoperative 120-hours
Incidence of Inpatient Sedation
Sedation will be assessed using the Ramsay Sedation Scale (RSS) and validated sedation scales extracted from the EMR. Outcome measure will be reported as n(%)
Measured: Postoperative 120-hours
QTc Prolongation
QTc prolongation is defined as more than 460 msec. Outcome measure will be reported as n(%).
Measured: Postoperative 48-hours
Length of Hospital Stay (LOS)
LOS will be recorded in days. Outcome measure will be reported as mean(SD).
Measured: Up to 30 days
Persistent Opioid Use
Based on Prescription Drug Monitoring Program (PDMP) and self-report data. Outcome measure will be reported as n(%)
Measured: 1-week, 1-month, and 3-months post-surgery
Presence of Chronic Postsurgical Pain (CPSP) at 3-months
CPSP incidence will be defined using NRS pain >3/10 and functional limitations based on Functional Disability Inventory (FDI). NRS pain scores are on a scale of 0=no pain at all and 10=worst pain imaginable. Outcome measure will be reported as n(%)
Measured: 3-months post-surgery
Presence of Opioid Dependence (OD) at 3-months
OD will be assessed using PROMIS and Prescription Pain Medication Misuse (PPMM). Outcome measure will be reported as n(%).
Measured: 3-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start17 Dec 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Cardiac SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senthil Sadhasivam
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Senthil Sadhasivam, University of Pittsburgh
- Investigators
- Senthilkumar Sadhasivam, MD, Principal investigator, University of PittsburghAlisha Maslanka, BS, Study director, University of Pittsburgh, UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626035
- Sponsor's protocol ID
- STUDY24040108
- Other IDs
- U01HD116257
- Acronym
- PRECISE
- Status last verified
- Apr 2026
- First submitted
- 15 Jun 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiable data and specimens will be shared with the sponsor of the study. The investigators and the study team will comply with all the NIH's Public Access and Data Sharing requirements including Release of Publications and Sharing of Underlying Primary Data. Release of Publications: The investigators will publish their results in open access journals for broad and free availability immediately without any embargo period. Electronic copies of publications will be deposited within four weeks of acceptance by a journal in PubMed Central with proper metadata to be made discoverable and accessible upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)
- ClinicalTrials.gov ID
- NCT06626035
- Acronym / sponsor ID
- PRECISE / STUDY24040108
- Conditions
- Pediatric Cardiac Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Senthil SadhasivamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 3 Oct 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 purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Randomly assigning means that there is a 50/50 chance, like a coin flip, of being assigned to either research group.
Detailed description
SPECIFIC AIMS. The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Cardiac) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing, and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after cardiac surgery (CS) in children.
The long-term goal is to proactively improve the safety and efficacy of surgical pain control while reducing opioid AEs and the opioid epidemic burden in all children undergoing inpatient surgeries. The central hypothesis is that a standardized, multidose, methadone-based ERAS protocol will reduce acute surgical pain, overall opioid use, RD, PONV, and CPSP compared with standard-of-care short-acting opioid-based analgesia in children undergoing CS (Aim 1). Investigators will use PK and genetic variations along with CPB-related dilution and clinical factors to develop optimal intra- and post-operative methadone dosing in children to enable precision analgesia in the future (Aim 2). Finally, the study team will identify patient profiles with genetic, epigenetic, PK, clinical, and psychological factors to predict benefit from assigned analgesia for optimal clinical outcomes (Aim 3). The expert multidisciplinary and multicenter team will enroll a total of 1000 children to conduct two parallel randomized clinical trials for CS (500 children 1 month-18 yrs from 5 clinical sites). In this study, specifically, Investigators will:
Aim 1. Conduct a randomized trial in CS to compare acute pain relief, opioid-sparing efficacy, and safety of standardized perioperative multidose methadone-based ERAS vs. standard-of-care non-methadone-based analgesia. Acute surgical pain, opioid needs (morphine equivalents), RD, PONV, and CPSP will be lower in methadone-based analgesia compared to short-acting opioid-based analgesia.
Aim 2. Develop precision methadone dosing based on age, CYP2B6 and ORM1 variants, AAG, and CPB. Age, CYP2B6 and ORM1 variants, AAG levels, and CPB-related dilution will explain methadone's PK variability and dose adjustments that correlate with optimal clinical outcomes among 500 children receiving methadone.
Aim 3. Identify patient profiles that predict benefits from the assigned analgesia protocol to optimize clinical outcomes. Personalized risk prediction models will be developed and validated including genetic variants (i.e., CYP2B6, CYP2D6, ABCB1, OPRM1, and FAAH), and psychological and clinical factors to predict benefit with the assigned treatments (methadone or non-methadone) for pre-specified clinical endpoints (i.e., lower acute surgical pain, RD, PONV, OD, and CPSP).
Overall Impact: The study team will develop actionable evidence for the efficacy of standardized, multidose, methadone-based ERAS protocols and will harness genetic, clinical, and psychological factors contributing to variability in methadone and oxycodone PK, acute surgical pain, transition to CPSP, opioid-induced PONV, RD, and dependence to develop personalized analgesia strategy and dosing for children undergoing CS. Implementation of evidence-based standardized methadone-based ERAS pain management and individualized risk prediction will maximize acute surgical pain relief while minimizing opioid use and AEs in millions of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Methadone-Based ERAS Group | Experimental | Drug: Methadone based ERASThe methadone-based standardized analgesia intervention arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting. |
| Non-Methadone-Based Group | Active comparator | Drug: Non-methadone based groupChildren randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Children aged 3-years - <18 years
- ASA physical status 1, 2, or 3
- Participant or legal guardian can speak and read English or Spanish
- Undergoing the following cardiac surgeries (Categories 1 \& 2) that are associated with significant acute surgical pain
- ASD, PFO closure
Key exclusion criteria (7 listed)
- Pregnant patients
- Methadone allergy
- Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
- Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)
- Preoperative opioid use within 30 days before surgery
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 |
|---|---|---|
| Methadone based ERASAlso: Methadone-BasedChildren randomized to the methadone arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting. | Drug | Methadone-Based ERAS Group |
| Non-methadone based groupAlso: Standard CareChildren randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. | Drug | Non-Methadone-Based Group |
Primary outcome
Average postoperative pain scores
Time frame: Postoperative 48 hours
Average postoperative pain scores within 48 hours of surgery (Numerical Rating Scale [NRS], or Facial expression, Leg movement, Activity, Cry, and Consolability [FLACC], both 0-10). Outcome will be reported based on area under the curve (AUC) as mean(SD).
Total postoperative opioid use
Time frame: Postoperative 48 hours
Total Opioid use in Morphine Milligram Equivalents (MME), will be reported as mean (SD).
8 secondary outcomes
Incidence of Inpatient Respiratory Depression (RD)
Time frame: Postoperative 120-hours
Incidence of Inpatient Postoperative Nausea and Vomiting (PONV)
Time frame: Postoperative 120-hours
Incidence of Inpatient Sedation
Time frame: Postoperative 120-hours
QTc Prolongation
Time frame: Postoperative 48-hours
Length of Hospital Stay (LOS)
Time frame: Up to 30 days
Persistent Opioid Use
Time frame: 1-week, 1-month, and 3-months post-surgery
Presence of Chronic Postsurgical Pain (CPSP) at 3-months
Time frame: 3-months post-surgery
Presence of Opioid Dependence (OD) at 3-months
Time frame: 3-months post-surgery
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 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Identifiable data and specimens will be shared with the sponsor of the study. The investigators and the study team will comply with all the NIH's Public Access and Data Sharing requirements including Release of Publications and Sharing of Underlying Primary Data. Release of Publications: The investigators will publish their results in open access journals for broad and free availability immediately without any embargo period. Electronic copies of publications will be deposited within four weeks of acceptance by a journal in PubMed Central with proper metadata to be made discoverable and accessible upon publication.
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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.
Dayana Alsamsam, BSPS, MSc contact
Senthilkumar Sadhasivam, MD principal investigator
University of Pittsburgh
Alisha Maslanka, BS study director
University of Pittsburgh, UPMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone based ERAS and Non-methadone based group in people with Pediatric Cardiac Surgery, run by Senthil Sadhasivam at 3 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 18 inclusion and 7 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 7 Aug 2026. 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 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. 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?
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 Senthilkumar Sadhasivam, MD,MPH, MBA, FASA (4126474484, sadhasivams@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average postoperative pain scores (time frame: Postoperative 48 hours). The study lists 2 primary outcomes in all. 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 7 Aug 2026.