Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke (RESPECT-ETB)

June 19, 2026 updated by: Pharmazz, Inc.

A Multicentric, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke.

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A stroke is a syndrome defined as an abrupt neurological outburst due to impaired blood flow to part of the brain. There are two types of stroke: hemorrhagic stroke and ischemic stroke. A hemorrhagic stroke follows the rupture of a weakened blood vessel in the brain causing accumulation of blood and compression of the surrounding brain tissue. An ischemic stroke follows a blocked blood vessel by a thrombus (blood clot) or embolism. In both types of strokes, the specific region of the brain supplied by the affected blood vessel is deprived of oxygenated blood, causing local hypoxia that damages the brain tissue and cells. Both types of stroke are very serious, however ischemic stroke is more common.

The global burden of ischemic stroke is nearly 4-fold greater than hemorrhagic stroke with close to 87% of the total incidence of stroke attributed to acute cerebral ischemic stroke (ACIS). ACIS is a critical care emergency caused by a significant reduction in blood flow to the brain by a blood clot or embolism. This nearly halts cerebral blood flow to the affected region leading to neuronal death. Neuronal cell death is followed by plasma membrane disruption, swelling of organelles, leaking of cell contents into extracellular space, and loss of neuronal function. Other events that take place include inflammation, excitotoxicity, free radical mediated toxicity, cytokine mediated cytotoxicity, impaired blood-brain-barrier, and oxidative stress.

Therapeutic management of ACIS is a multidisciplinary approach with a primary goal of revascularization and limiting neuronal injury. A stroke team consists of emergency medicine physicians, neurologists/neurosurgeons, radiologists, nurses and advanced care providers, clinical pharmacists, therapists, technicians, and laboratory personnel. Currently, the only FDA-approved pharmacological agent for ischemic stroke is tissue plasminogen activator (t-PA). It is a thrombolytic agent which restores blood flow by breaking down a clot. However, timing is crucial in administration of t-PA as the therapeutic time window is very narrow and the patient must receive it within 4.5 hours of onset of stroke symptoms. Therapeutic administration after this timeframe can result in hemorrhagic transformation, leading to additional brain damage. Nevertheless, even upon timely administration of t-PA in ACIS, only about 30% of patients obtain stroke resolution having minimal or no disability at the 90-day mark.

Sovateltide (PMZ-1620, IRL-1620) is a highly selective ETB receptor agonist and a synthetic analog of ET-1. Studies conducted to determine the effects brought about by sovateltide upon its interaction with neural ETB receptors and have found that it enhances angiogenesis and neurogenesis as well as promotes neural repair and regeneration. In a rat model of ischemic stroke, sovateltide was found to be neuroprotective as well as enhance angiogenic and neurogenic remodeling. Sovateltide significantly improved survival, reduced neurological and motor function deficit, while effectively decreasing infarct volume, edema, and oxidative stress.

Sovateltide was also found to be safe and well tolerated in healthy human volunteers in a phase I clinical trial (CTRI/2016/11/007509). A phase II study was also conducted in patients with acute ischemic stroke where sovateltide demonstrated significant improvement when compared to standard of care (CTRI/2017/11/010654, NCT04046484). A recent phase III study conducted in patients of acute ischemic stroke demonstrated improved favorable functional and neurological outcome at 3 months compared to standard of care (CTRI/2019/09/021373, NCT04047563).

Clinical phase II and III results indicate that sovateltide is a first-in-class neuronal progenitor cell therapeutic that promotes quick recovery and significantly improves neurological outcomes in cerebral ischemic stroke patients. With this convincing evidence, the plan is to conduct a multicentric, randomized, double-blind, parallel, placebo-controlled phase III clinical study in the United States, Canada, United Kingdom and Europe (the demographics and standard of treatment being similar in these countries) to further assess the safety and efficacy of sovateltide in patients with acute cerebral ischemic stroke.

Study Type

Interventional

Enrollment (Estimated)

514

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bad Neustadt an der Saale, Germany, 97616
      • Erlangen, Germany, 91054
      • Essen, Germany, 45147
        • Recruiting
        • Universitätsklinikum Essen AöR
        • Contact:
          • Prof. Dr. med. Martin Köhrmann
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein AöR
        • Contact:
          • Prof. Dr. George Royl
      • Tübingen, Germany
    • Altenburg
      • Altenburg, Altenburg, Germany, 04600
        • Recruiting
        • Klinikum Altenburger Land GmbH
        • Contact:
          • Joerg Berrouschot
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Recruiting
        • Universitaetsklinikum Goettingen
        • Contact:
          • Ilko Maier
    • Ludwigshafen Am
      • Rhein, Ludwigshafen Am, Germany, 67063
        • Recruiting
        • Klinikum der Stadt Ludwigshafen gGmbh
        • Contact:
          • Dr Simon Nagel
    • North Rhine-Westphalia
      • Minden, North Rhine-Westphalia, Germany, 32427
        • Recruiting
        • Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik
        • Contact:
          • Dr Peter Schellinger
    • Recklinghausen
      • Recklinghausen, Recklinghausen, Germany, 45657
        • Recruiting
        • Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151
        • Contact:
          • Dr Stephan Klebe
    • State of Berlin
      • Berlin, State of Berlin, Germany, 12203
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Instituto de Investigacion Biomedica de A Coruna
        • Contact:
          • Dr Maria del Mar Castellanos Rodrigo
      • Badajoz, Spain, 06080
        • Recruiting
        • Hospital Universitario Infanta Cristina (HUB)
        • Contact:
          • Dr Jose Maria Ramirez Moreno
      • Barakaldo, Spain, 48903
        • Recruiting
        • Hospital Universitario de Cruces
        • Contact:
          • Dr Mari Mar Freijo Guerrero
      • Girona, Spain, 17007
        • Recruiting
        • Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta
        • Contact:
          • Dr Yolanda Silva Blas
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon Y Cajal
        • Contact:
          • Dr Jaime Masjuan Vallejo
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Dr Jose Antonio Egido Herrero
      • Melilla, Spain, 52001
      • Santiago, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago
        • Contact:
          • Dr Manuel Rodriguez Yanez
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • Dr Francisco Moniche Alvarez
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
          • Dr. Alejandro Ponz
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe de Valencia
        • Contact:
          • Dr Irene Escudero Martinez
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Dr Herbert Tejada Meza
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
          • María Hernández Pérez
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Carlos Alberto Molina Cateriano
    • Castille-La Mancha
      • Albacete, Castille-La Mancha, Spain, 2006
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
        • Contact:
          • Dr Tomas Segura Martin
    • Madrid
      • Madrid, Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Exuperio Díez Tejedor
      • Madrid, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Dr Joaquin Carneado Ruiz
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de Arrixaca
        • Contact:
          • Dr Ana Morales Ortiz
    • Sevilla
      • Seville, Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Soledad Pérez Sánchez
    • Tarragona
      • Tarragona, Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitari Joan XXIII
        • Contact:
          • Dr Xavier Ustrell Roig
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Recruiting
        • London North West University Healthcare NHS Trust - Northwick Park Hospital
        • Contact:
      • Newcastle, United Kingdom, NE1 4LP
        • Recruiting
        • Hospitals NHS Foundation Trust - Royal Victoria Infirmary RVI
        • Contact:
          • Dr. Anand Dixit
      • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Bury
      • Bury, Bury, United Kingdom, BL9 7TD
        • Recruiting
        • Fairfield General Hospital
        • Contact:
          • Dr Narayanamoorthi Saravanan
    • London
      • London, London, United Kingdom, NW1 2BU
        • Recruiting
        • National Hospital for Neurology & Neurosurgery
        • Contact:
          • Dr Richard Perry
      • London, London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
          • Dr Yee Mah
      • London, London, United Kingdom, SW17 0QT
    • Southampton
      • Southampton, Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton
        • Contact:
          • Dr Richard Marigold
    • Wolverhampton
      • Wolverhampton, Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • New Cross Hospital - Royal Wolverhampton NHS Trust
        • Contact:
          • Dr Nasar Ahmad
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
    • California
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy Medical Group
        • Contact:
          • Lucian Maidan, MD
      • Oxnard, California, United States, 93030
        • Recruiting
        • St. John's Regional Medical Center
        • Contact:
          • Mani Nezhad
    • Florida
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
          • Dr. Mauricio Concha
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Wellstar Kennestone Hospital
        • Contact:
          • Dr. Ovais Inamullah
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Recruiting
        • SSM Health Neurosciences
        • Contact:
          • Amer Alshekhlee, MD
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • Hackensack University Medical Center at Paramus
        • Contact:
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Guilford Neurologic Associates Inc
        • Contact:
          • Dr. Pramod Sethi
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • OSU Wexner Medical Center
        • Contact:
          • Yousef Hannawi
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian Hospital
        • Contact:
          • Dr Jussie Correia Lima
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • CHI Memorial Neuroscience Institute
        • Contact:
          • Thomas Devlin
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Hospital
        • Contact:
          • Mahan Shahrivari, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Medical Neurological Institute
        • Contact:
          • David Chui, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A patient will be eligible for inclusion in the study if he/she fulfills the following criteria:

  1. Adult males or females aged 18 - 80 years of age.
  2. Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.
  3. A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
  4. Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and <20, NIHSS Level of Consciousness (1A) score <2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.
  5. The patient is <24 hours from the time of stroke onset when the first dose of sovateltide is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self- reported to be normal.
  6. Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria:

  1. Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.
  2. Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥2).
  3. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
  4. Known pregnancy and lactating women.
  5. Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study.
  6. Concurrent participation in any other therapeutic clinical trial.
  7. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal Saline + Standard of care
Normal saline will be used as a comparator. It will be available in a 5.0 mL vial. Three doses will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.
Drug: Drug: Normal Saline
Normal saline to be used as vehicle in the phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Other Names:
  • Vehicle
Experimental: Sovateltide + Standard of care
The test product is sovateltide. It is available as a lyophilized injection containing 30 µg of sovateltide in a 5.0 mL vial. Three doses of 0.3 μg/kg will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.
Drug: Sovateltide
Phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Other Names:
  • PMZ-1620

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the efficacy of sovateltide in patients with acute cerebral ischemic stroke assessed by modified Rankin Scale (mRS) score of 0-2 at day 90 post-randomization.
Time Frame: Day 1 through Day 90
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale score of 0-2 on day 90 post-randomization.
Day 1 through Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the National Institute of Health Stroke Scale (NIHSS) score of <6 at day 90 post-randomization.
Time Frame: Day 1 through Day 90
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of <6 on day 90 post-randomization.
Day 1 through Day 90
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the Barthel Index (BI) score of ≥90 at day 90 post-randomization.
Time Frame: Day 1 through Day 90
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 90 post-randomization.
Day 1 through Day 90
Determine an excellent functional outcome in patients with acute cerebral ischemic stroke assessed by a modified Rankin Scale score of 0-1 at day 90 post-randomization.
Time Frame: Day 1 through Day 90
The proportion of acute cerebral ischemic stroke patients having an excellent functional outcome with a modified Rankin Scale score of 0-1 on day 90 post-randomization.
Day 1 through Day 90
Determine the incidence of mortality within 90 days post-randomization.
Time Frame: Day 1 through Day 90
Number of deaths within day 90 post-randomization.
Day 1 through Day 90
Determine the incidence of symptomatic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization.
Time Frame: Day 1 through Day 90
The proportion of patients with symptomatic ICH within 24 (± 6) hours of randomization.
Day 1 through Day 90
Determine the incidence of radiographic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization.
Time Frame: Day 1 through Day 90
The proportion of patients with radiographic ICH within 24 (± 6) hours of randomization.
Day 1 through Day 90
Determine alteration in cognition at days 30 and 90 measured by Montreal Cognitive Assessment (MoCA) Test.
Time Frame: Day 1 through Day 90
Change in MoCA score at days 30 and 90 post-randomization.
Day 1 through Day 90
Determine any adverse events (AE) or serious adverse events (SAEs) are associated with sovateltide.
Time Frame: Day 1 through Day 90
The proportion of patients with adverse events (AEs) and serious adverse events (SAEs).
Day 1 through Day 90
Determine a change in Quality-of-life (QoL) as assessed by EuroQol-EQ-5D-5L and Stroke-Specific Quality of Life (SS-QOL) at days 30, 60, and 90 post-randomization.
Time Frame: Day 1 through Day 90
Change in QoL as assessed by EuroQol EQ-5D-5L and by SS-QOL from baseline to days 30, 60, and 90 post-randomization.
Day 1 through Day 90
Determine the incidence of recurrent cerebral ischemic stroke within 90 days post-randomization.
Time Frame: Day 1 through Day 90
The proportion of patients with recurrent ischemic stroke within 90 days post-randomization.
Day 1 through Day 90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by mRS score of 0-2 at day 30 post-randomization.
Time Frame: Day 1 through Day 30
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with a mRS score of 0-2 on day 30 post-randomization.
Day 1 through Day 30
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the NIHSS score of <6 at day 30 post-randomization.
Time Frame: Day 1 through Day 30
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of <6 on day 30 post-randomization.
Day 1 through Day 30
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the BI score of ≥90 at day 30 post-randomization.
Time Frame: Day 1 through Day 30
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 30 post-randomization.
Day 1 through Day 30
Determine Alberta Stroke Program Early CT (ASPECT) Score for stroke severity at baseline and identify sites of ischemic lesions.
Time Frame: Day 1 through Day 90
Compare baseline Alberta Stroke Program Early CT (ASPECT) Score for stroke severity and identify sites of ischemic lesions.
Day 1 through Day 90
Determine the subtype of acute cerebral ischemic stroke according to TOAST classification at day 30 post-randomization.
Time Frame: Day 1 through Day 30
Compare the subtype of acute cerebral ischemic stroke by TOAST classification at day 30 post-randomization.
Day 1 through Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmazz, Inc.

Investigators

  • Study Chair: Anil Gulati, MD, PhD, Pharmazz, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sovateltide/ACIS/IND2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Following completion of the trial in 2027, the anonymized patient datasets created and/or analyzed for the current study can be accessed from the corresponding author at a reasonable request from a bona fide researcher/research group.

IPD Sharing Time Frame

December 2027

IPD Sharing Access Criteria

Following completion of the trial in 2027, the anonymized patient datasets created and/or analyzed for the current study can be accessed from the corresponding author at a reasonable request from a bona fide researcher/research group.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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