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Pulmonary Embolism AcutePhase 4REDSTEMNCT07816978

Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism

A Phase 4 study testing Reduced-dose alteplase and Full-dose alteplase in people with Pulmonary Embolism Acute, run by Sahlgrenska University Hospital at 23 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

High-risk pulmonary embolism is a life-threatening condition requiring immediate reperfusion therapy. Full-dose systemic thrombolysis is recommended as first-line treatment, but its use is limited by the risk of major bleeding, including intracranial hemorrhage. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism Acute
What is being tested?
Reduced-dose alteplase and Full-dose alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
23 sitesin 3 countries
Study dates
1 Dec 2026to 31 Jan 2031
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant aged 18 years or older.
  • Acute pulmonary embolism verified by computed tomography pulmonary angiography or pulmonary angiography. In hemodynamically unstable participants unable to undergo immediate imaging, presumed pulmonary embolism may be diagnosed based on bedside echocardiographic findings consistent with acute right ventricular pressure overload and high clinical suspicion of pulmonary embolism, provided that alternative causes of hemodynamic instability have been reasonably excluded. In such cases, the treating clinician must have independently decided to initiate thrombolytic therapy irrespective of study participation, and confirmatory imaging demonstrating pulmonary embolism must be performed as soon as clinically feasible.
  • High risk for early death, defined by at least one of the following:
  • High-risk pulmonary embolism according to European Society of Cardiology criteria:
  • Cardiac arrest with return of spontaneous circulation;
  • Obstructive shock, defined as systolic blood pressure <90 mmHg or use of vasopressors to maintain systolic blood pressure ≥90 mmHg despite adequate filling status, together with end-organ hypoperfusion such as elevated serum lactate >2 mmol/L, altered mental status, or cold clammy skin;
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  • Persistent hypotension, defined as systolic blood pressure <90 mmHg or a drop in systolic blood pressure ≥40 mmHg for longer than 15 minutes, not caused by new-onset arrhythmia, hypovolemia, or sepsis.
  • Abnormal right ventricular function on echocardiography or computed tomography pulmonary angiography, defined as right ventricular/left ventricular ratio ≥1.0, and elevated cardiac troponin above the local upper reference limit, and acute respiratory failure not primarily caused by underlying lung disease, defined as requiring facemask oxygen supplementation ≥12 L/min, high-flow nasal oxygen, or non-invasive ventilation with FiO2 ≥60% to reach oxygen saturation ≥94%.
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test.

Who cannot join

  • Catastrophic pulmonary embolism, defined as ongoing cardiac arrest and/or need for extracorporeal cardiopulmonary resuscitation and/or immediate VA-ECMO as judged by the treating physicians.
  • Known hypersensitivity to alteplase or any of its excipients.
  • Contraindication to systemic thrombolysis with one or more of the following:
  • History of hemorrhagic stroke;
  • Ischemic stroke within the previous 6 months;
  • Central nervous system neoplasm;
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  • Major trauma, major surgery, or major head injury within the previous 3 weeks;
  • Active life-threatening bleeding, bleeding into a critical organ or area, or known severe bleeding diathesis;
  • Chronic use of full-dose oral or parenteral anticoagulation before presentation.
  • The participant has already received reperfusion treatment for the index pulmonary embolism before randomization, including systemic thrombolysis, surgical embolectomy, or catheter-directed intervention.
  • Pregnancy.
  • Current participation in another study that would interfere with participation in this trial.
  • Any other condition that would put the participant at unacceptable risk from the trial interventions as judged by the treating clinician.
  • In countries where required by national regulations: lack of affiliation to a social security system or equivalent health insurance coverage.

Trial locations and contacts

23 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Kristina Svennerholm, MD PhD contact

+46313421000

kristina.svennerholm@vgregion.se

Annika Odenstedt, Coordinator contact

+46313421000

annika.odenstedt@vgregion.se

23 sites in 3 countries

Sweden16 sites

  • Falun Hospital

    Falun

    Jessica Silfverberg, MD

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götaland County, 413 45

    Kristina Svennerholm, MD, PhD, kristina.svennerholm@vgregion.se

    Annika Odenstedt, annika.odenstedt@vgregion.se

  • Sahlgrenska University Hospital/Östra

    Gothenburg

    Katarina Glise Sandblad, MD, PhD

  • Ryhov County Hospital

    Jönköping

    Antheia Kissopoulou, MD, PhD

  • Skåne University Hospital, Lund

    Lund

    Marcus Ohlsson, MD

  • Skåne University Hospital, Malmö

    Malmö

    Marcus Ohlsson, MD, PhD

  • Sahlgrenska University Hospital/Mölndal

    Mölndal

    Louise Martinell, MD, PhD

  • Norrtälje Hospital

    Norrtälje

    Sune Forsberg, MD, PhD

  • Skaraborgs Hospital Skövde

    Skövde

    Freyr Einarsson, MD

    Erik Ullemark, MD

  • Capio S:t Göran's Hospital

    Stockholm

    Rickard Markgren, MD, PhD

  • Danderyd Hospital

    Stockholm

    Nina Olausson, MD, PhD

  • Karolinska University Hospital, Huddinge

    Stockholm

    Therese Djärv, MD, PhD

  • Karolinska University Hospital, Solna

    Stockholm

    Therese Djärv, MD, PhD

  • Södersjukhuset, Stockholm South General Hospital

    Stockholm

    Jacob Hollenberg, MD, PhD

  • University Hospital of Umeå

    Umeå

    Johanna Pennlert, MD, PhD

  • Uppsala University Hospital

    Uppsala

    Sofia Vikman, MD, PhD

Other trials in Sweden

Norway6 sites

  • Haukeland University Hospital

    Bergen, 5021

    Lasse Melvear Gii, MD, PhD

  • Drammen Hospital

    Drammen, 3004

    Jonas Pivoriunas, MD, PhD

  • Ostfold Hisptal

    Grålum, 1714

    Hans Joakim Myklebust-Hansen, MD

  • Akershus University Hospital

    Lörenskog, 1478

    Hamza Nahoui, MD

  • Oslo University Hospital, Ullevål

    Oslo, 0450

    Mari Asphjell Björnaas, MD, PhD

  • Stavanger University Hospital

    Stavanger, 4021

    Trond Johan Cooper, MD

Other trials in Norway

Denmark1 site

  • Rigshospitalet

    Copenhagen

    Jesper Kjaergaard, MD, PhD

Other trials in Denmark

About this study

Official title: Reduced-Dose Versus Full-Dose Systemic Thrombolysis for High-Risk Pulmonary Embolism: A Multicentre, Randomised, Open-Label, Blinded-Endpoint Trial

High-risk pulmonary embolism is a life-threatening condition requiring immediate reperfusion therapy. Full-dose systemic thrombolysis is recommended as first-line treatment, but its use is limited by the risk of major bleeding, including intracranial hemorrhage. Reduced-dose systemic thrombolysis may reduce bleeding while maintaining clinical efficacy, but this strategy has not been adequately evaluated in patients with high-risk pulmonary embolism.

REDSTEM is an international, multicenter, randomized, adaptive, open-label, blinded-endpoint phase 4 trial comparing reduced-dose alteplase with standard full-dose alteplase in adults with acute high-risk pulmonary embolism. The trial will assess whether reduced-dose alteplase preserves early clinical efficacy while reducing severe clinically significant bleeding. Participants will be followed for up to 12 months.

Read the detailed description

Systemic thrombolysis is recommended as first-line reperfusion therapy for high-risk pulmonary embolism. However, bleeding complications limit its use in clinical practice and contribute to undertreatment of eligible patients. Existing evidence from small randomized trials, observational studies, and meta-analyses suggests that lower-dose thrombolysis may improve safety while maintaining efficacy, but previous studies have included mixed-risk pulmonary embolism populations and only a limited number of patients with high-risk pulmonary embolism.

REDSTEM was designed to evaluate whether a reduced-dose alteplase strategy can provide a more favorable balance between efficacy and safety compared with standard full-dose alteplase in patients with high-risk pulmonary embolism. The study uses randomized treatment allocation, blinded endpoint adjudication, independent safety monitoring, and an adaptive design allowing sample-size re-estimation if required.

The trial includes early clinical assessments during the acute phase and follow-up through 12 months to evaluate clinical outcomes, safety, functional recovery, quality of life, and health care resource utilization.

Being tested
Reduced-dose alteplase, Full-dose alteplase
Keywords
Systemic thrombolysis, Efficacy, Safety, Reduced-dose, Alteplase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reduced-dose alteplaseDrug

    Also called Reduced-dose systemic thrombolysis, Low-dose alteplase, tPA

    Alteplase 0.6 mg/kg body weight, maximum 50 mg, administered as an intravenous infusion over 15 minutes

  • Full-dose alteplaseDrug

    Also called Full-dose systemic thrombolysis, Standard-dose alteplase, tPA

    Alteplase 1.5 mg/kg body weight, maximum 100 mg, administered as a 10 mg intravenous bolus over 1 to 2 minutes followed by 90 mg as an intravenous infusion over 2 hours.

Study groups in NCT07816978
Study groupRoleWhat they receive
Reduced-Dose AlteplaseExperimentalParticipants randomized to reduced-dose systemic thrombolysis will receive alteplase 0.6 mg/kg body weight, up to a maximum dose of 50 mg, administered intravenously over 15 minutes.
Receives: Drug: Reduced-dose alteplase
Full-Dose AlteplaseActive comparatorParticipants randomized to standard full-dose systemic thrombolysis will receive alteplase 1.5 mg/kg body weight, up to a maximum dose of 100 mg, administered as a 10 mg intravenous bolus over 1 to 2 minutes followed by a 90 mg intravenous infusion over 2 hours.
Receives: Drug: Full-dose alteplase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of composite efficacy endpoint

    Incidence of a composite endpoint comprising all-cause mortality within 7 days, cardiopulmonary resuscitation and/or veno-arterial extracorporeal membrane oxygenation within 7 days, recurrent pulmonary embolism within 7 days, clinical deterioration within 24 hours, and lack of clinical improvement at 6 hours after the start of IMP administration.

    Measured: Within 7 days after randomization

  2. Key secondary endpoint - Incidence of severe clinically significant bleeding

    Incidence of severe clinically significant bleeding, defined as major bleeding according to International Society on Thrombosis and Haemostasis criteria or bleeding requiring urgent medical intervention.

    Measured: Within 7 days after randomization

Secondary outcomes (16)

  1. All-cause mortality

    Incidence of death from any cause.

    Measured: At 7 days and 30 days after randomization

  2. Pulmonary embolism-related mortality

    Incidence of pulmonary embolism-related death.

    Measured: At 7 days and 30 days after randomization

  3. Cardiopulmonary resuscitation and/or VA-ECMO

    Incidence of cardiopulmonary resuscitation and/or veno-arterial extracorporeal membrane oxygenation.

    Measured: Within 7 days after randomization

  4. Incidence of clinical deterioration

    Incidence of clinical deterioration within the first 24 hours. During IMP administration, clinical deterioration is defined as life-threatening haemodynamic or respiratory decline requiring CPR, endotracheal intubation due to worsening life-threatening respiratory failure, or initiation of VA-ECMO. After IMP administration, clinical deterioration additionally includes an increase in SCAI SHOCK stage. The blinded CEC independently adjudicates whether and when SCAI deterioration occurred. A restricted eCRF calculation determines whether the deterioration occurred after IMP completion.

    Measured: Within 24 hours after the start of IMP administration

  5. Lack of clinical improvement assessed by SCAI SHOCK stage and oxygen requirement

    Lack of clinical improvement at 6 hours is defined as unchanged SCAI SHOCK stage in participants included according to ESC high-risk PE criteria or, for participants included due to respiratory failure criteria without fulfilling ESC high-risk PE criteria, unchanged or increasing FiO₂ required to maintain SpO₂ ≥94% and/or unchanged or decreasing PaO₂/FiO₂ ratio

    Measured: At 6 hours (+1h) after the start of IMP administration

  6. Time to clinical stabilization based on predefined hemodynamic and respiratory criteria

    Time from the start of IMP administration (T0) to the time point at which the predefined clinical stabilisation criteria have been continuously fulfilled for at least 30 minutes. For participants included according to ESC high-risk PE criteria, haemodynamic stabilisation is defined as SBP ≥90 mmHg or MAP ≥65 mmHg without vasoactive drugs or mechanical circulatory support during this period. For participants included due to respiratory failure without ESC high-risk PE, respiratory stabilisation is defined as SpO₂ ≥94% (or a predefined target) with facemask oxygen ≤8 L/min or HFNO/NIV with FiO₂ ≤50%, without intubation, maintained for at least 30 minutes.

    Measured: From the start of IMP administration until clinical stabilization, assessed up to 7 days after randomization

  7. Incidence of recurrent pulmonary embolism

    Incidence of objectively confirmed recurrent pulmonary embolism.

    Measured: At 7 days and 30 days after randomization

  8. Initiation of invasive or non-invasive mechanical ventilation

    Incidence of initiation of invasive or non-invasive mechanical ventilation.

    Measured: Within 7 days after randomization

  9. Win ratio for efficacy

    Win ratio based on all-cause mortality, cardiopulmonary resuscitation and/or VA-ECMO, clinical deterioration, lack of clinical improvement, recurrent pulmonary embolism, and time to clinical stabilization.

    Measured: Within 7 days after randomization

  10. Net clinical benefit

    Composite net clinical benefit including severe clinically significant bleeding, all-cause mortality, cardiopulmonary resuscitation and/or VA-ECMO, recurrent pulmonary embolism, clinical deterioration, and lack of clinical improvement.

    Measured: Within 7 days after randomization

  11. Rescue treatment

    Need for rescue treatment, defined as additional alteplase, catheter-directed intervention, surgical embolectomy, or VA-ECMO before stabilization.

    Measured: Before clinical stabilization, up to 7 days after randomization

  12. ICU or high-dependency unit length of stay in days

    Length of stay in intensive care unit and/or high-dependency unit.

    Measured: Within 30 days after randomization

  13. Hospital length of stay

    Length of hospital stay.

    Measured: Within 30 days after randomization

  14. Major bleeding

    Incidence of major bleeding according to International Society on Thrombosis and Haemostasis criteria.

    Measured: At 48 hours, 7 days, and 30 days after randomization

  15. Bleeding requiring urgent medical intervention

    Incidence of severe bleeding requiring urgent medical intervention.

    Measured: At 48 hours, 7 days, and 30 days after randomization

  16. Intracranial bleeding

    Incidence of intracranial bleeding.

    Measured: Within 7 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion31 Jan 2030 (estimated)
  4. Study completion31 Jan 2031 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:1 ratio to reduced-dose alteplase or standard full-dose alteplase.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07816978
Sponsor's protocol ID
REDSTEM
Other IDs
2024-515904-37-00
Acronym
REDSTEM
Status last verified
Oct 2026
First submitted
2 Sep 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published results may be shared upon reasonable request after publication. Access will require approval by the sponsor and principal investigator, a scientifically sound proposal, scientific collaboration with the trial investigators, compliance with applicable ethical, regulatory, data protection, and consent requirements, and a signed data sharing agreement.

Publications

  • Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

    PubMed 31504429

  • Stevens SM, Woller SC, Kreuziger LB, Bounameaux H, Doerschug K, Geersing GJ, Huisman MV, Kearon C, King CS, Knighton AJ, Lake E, Murin S, Vintch JRE, Wells PS, Moores LK. Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guideline and Expert Panel Report. Chest. 2021 Dec;160(6):e545-e608. doi: 10.1016/j.chest.2021.07.055. Epub 2021 Aug 2.

    PubMed 34352278

  • Silver MJ, Giri J, Duffy A, Jaber WA, Khandhar S, Ouriel K, Toma C, Tu T, Horowitz JM. Incidence of Mortality and Complications in High-Risk Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Soc Cardiovasc Angiogr Interv. 2023 Jan 27;2(1):100548. doi: 10.1016/j.jscai.2022.100548. eCollection 2023 Jan-Feb.

    PubMed 39132523

  • Keller K, Hobohm L, Ebner M, Kresoja KP, Munzel T, Konstantinides SV, Lankeit M. Trends in thrombolytic treatment and outcomes of acute pulmonary embolism in Germany. Eur Heart J. 2020 Jan 21;41(4):522-529. doi: 10.1093/eurheartj/ehz236.

    PubMed 31102407

  • Wang C, Zhai Z, Yang Y, Wu Q, Cheng Z, Liang L, Dai H, Huang K, Lu W, Zhang Z, Cheng X, Shen YH; China Venous Thromboembolism (VTE) Study Group. Efficacy and safety of low dose recombinant tissue-type plasminogen activator for the treatment of acute pulmonary thromboembolism: a randomized, multicenter, controlled trial. Chest. 2010 Feb;137(2):254-62. doi: 10.1378/chest.09-0765. Epub 2009 Sep 9.

    PubMed 19741062

  • Goldhaber SZ, Agnelli G, Levine MN. Reduced dose bolus alteplase vs conventional alteplase infusion for pulmonary embolism thrombolysis. An international multicenter randomized trial. The Bolus Alteplase Pulmonary Embolism Group. Chest. 1994 Sep;106(3):718-24. doi: 10.1378/chest.106.3.718.

    PubMed 8082347

  • Melamed R, Tierney DM, Xia R, Brown CS, Mara KC, Lillyblad M, Sidebottom A, Wiley BM, Khapov I, Gajic O. Safety and Efficacy of Reduced-Dose Versus Full-Dose Alteplase for Acute Pulmonary Embolism: A Multicenter Observational Comparative Effectiveness Study. Crit Care Med. 2024 May 1;52(5):729-742. doi: 10.1097/CCM.0000000000006162. Epub 2024 Jan 3.

    PubMed 38165776

  • Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jimenez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2022 May;122(5):857-866. doi: 10.1055/a-1653-4699. Epub 2021 Oct 31.

    PubMed 34560806

  • Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

    PubMed 15842354

  • Stadlbauer A, Verbelen T, Binzenhofer L, Goslar T, Supady A, Spieth PM, Noc M, Verstraete A, Hoffmann S, Schomaker M, Hopler J, Kraft M, Tautz E, Hoyer D, Tongers J, Haertel F, El-Essawi A, Salem M, Rangel RH, Hullermann C, Kriz M, Schrage B, Moises J, Sabate M, Pappalardo F, Crusius L, Mangner N, Adler C, Tichelbacker T, Skurk C, Jung C, Kufner S, Graf T, Scherer C, Villegas Sierra L, Billig H, Majunke N, Speidl WS, Zilberszac R, Chiscano-Camon L, Uribarri A, Riera J, Roncon-Albuquerque R Jr, Terauda E, Erglis A, Tavazzi G, Zeymer U, Knorr M, Kilo J, Mobius-Winkler S, Schwinger RHG, Frank D, Borst O, Haberle H, De Roeck F, Vrints C, Schmid C, Nickenig G, Hagl C, Massberg S, Schafer A, Westermann D, Zimmer S, Combes A, Camboni D, Thiele H, Lusebrink E; High-risk P. E. Investigator Group. Management of high-risk acute pulmonary embolism: an emulated target trial analysis. Intensive Care Med. 2025 Mar;51(3):490-505. doi: 10.1007/s00134-025-07805-4. Epub 2025 Feb 25.

    PubMed 39998658

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Reduced-dose alteplase and Full-dose alteplase in people with Pulmonary Embolism Acute, run by Sahlgrenska University Hospital at 23 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Sweden, Norway, Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Kristina Svennerholm, MD PhD (+46313421000, kristina.svennerholm@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of composite efficacy endpoint (time frame: Within 7 days after randomization). 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?

On the ClinicalTrials.gov record for NCT07816978, which also lists 10 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 28 Oct 2026.

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