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Um estudo para avaliar a segurança e a eficácia da sovateltida em pacientes com AVC isquêmico cerebral agudo (RESPECT-ETB)

9 de novembro de 2026 atualizado por: Pharmazz, Inc.

Um estudo de Fase III multicêntrico, randomizado, duplo-cego, paralelo e controlado por placebo para avaliar a segurança e a eficácia de Sovateltide em pacientes com AVC isquêmico cerebral agudo.

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

514

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Alemanha
      • Bad Neustadt an der Saale, Alemanha, 97616
      • Erlangen, Alemanha, 91054
      • Essen, Alemanha, 45147
        • Recrutamento
        • Universitätsklinikum Essen AöR
        • Contato:
          • Prof. Dr. med. Martin Köhrmann
      • Lübeck, Alemanha, 23538
        • Recrutamento
        • Universitätsklinikum Schleswig-Holstein AöR
        • Contato:
          • Prof. Dr. George Royl
      • Tübingen, Alemanha
    • Altenburg
      • Altenburg, Altenburg, Alemanha, 04600
        • Recrutamento
        • Klinikum Altenburger Land GmbH
        • Contato:
          • Joerg Berrouschot
    • Lower Saxony
      • Göttingen, Lower Saxony, Alemanha, 37075
        • Recrutamento
        • Universitaetsklinikum Goettingen
        • Contato:
          • Ilko Maier
    • Ludwigshafen Am
      • Rhein, Ludwigshafen Am, Alemanha, 67063
        • Recrutamento
        • Klinikum der Stadt Ludwigshafen gGmbh
        • Contato:
          • Dr Simon Nagel
    • North Rhine-Westphalia
      • Minden, North Rhine-Westphalia, Alemanha, 32427
        • Recrutamento
        • Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik
        • Contato:
          • Dr Peter Schellinger
    • Recklinghausen
      • Recklinghausen, Recklinghausen, Alemanha, 45657
        • Recrutamento
        • Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151
        • Contato:
          • Dr Stephan Klebe
    • State of Berlin
      • Berlin, State of Berlin, Alemanha, 12203
  • Austrália
    • New South Wales
  • Espanha
      • A Coruña, Espanha, 15006
        • Recrutamento
        • Instituto de Investigación Biomédica de A Coruña
        • Contato:
          • Dr Maria del Mar Castellanos Rodrigo
      • Badajoz, Espanha, 06080
        • Recrutamento
        • Hospital Universitario Infanta Cristina (HUB)
        • Contato:
          • Dr Jose Maria Ramirez Moreno
      • Barakaldo, Espanha, 48903
        • Recrutamento
        • Hospital Universitario de Cruces
        • Contato:
          • Dr Mari Mar Freijo Guerrero
      • Girona, Espanha, 17007
        • Recrutamento
        • Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta
        • Contato:
          • Dr Yolanda Silva Blas
      • Madrid, Espanha, 28034
        • Recrutamento
        • Hospital Universitario Ramon y Cajal
        • Contato:
          • Dr Jaime Masjuan Vallejo
      • Madrid, Espanha, 28040
        • Recrutamento
        • Hospital Clinico San Carlos
        • Contato:
          • Dr Jose Antonio Egido Herrero
      • Melilla, Espanha, 52001
      • Santiago, Espanha, 15706
        • Recrutamento
        • Hospital Clinico Universitario de Santiago
        • Contato:
          • Dr Manuel Rodriguez Yanez
      • Seville, Espanha, 41013
        • Recrutamento
        • Hospital Universitario Virgen del Rocio
        • Contato:
          • Dr Francisco Moniche Alvarez
      • Valencia, Espanha, 46026
        • Recrutamento
        • Hospital Universitari i Politecnic La Fe de Valencia
        • Contato:
          • Dr Irene Escudero Martinez
      • Valencia, Espanha, 46010
        • Recrutamento
        • Hospital Clinico Universitario de Valencia
        • Contato:
          • Dr. Alejandro Ponz
      • Zaragoza, Espanha, 50009
        • Recrutamento
        • Hospital Universitario Miguel Servet
        • Contato:
          • Dr Herbert Tejada Meza
    • Barcelona
      • Badalona, Barcelona, Espanha, 08916
        • Recrutamento
        • Hospital Germans Trias i Pujol
        • Contato:
          • María Hernández Pérez
      • Barcelona, Barcelona, Espanha, 08035
        • Recrutamento
        • Hospital Universitari Vall d'Hebron
        • Contato:
          • Carlos Alberto Molina Cateriano
    • Castille-La Mancha
      • Albacete, Castille-La Mancha, Espanha, 2006
        • Recrutamento
        • Complejo Hospitalario Universitario de Albacete
        • Contato:
          • Dr Tomas Segura Martin
    • Madrid
      • Madrid, Madrid, Espanha, 28046
        • Recrutamento
        • Hospital Universitario La Paz
        • Contato:
          • Exuperio Díez Tejedor
      • Madrid, Madrid, Espanha, 28222
        • Recrutamento
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contato:
          • Dr Joaquin Carneado Ruiz
    • Murcia
      • El Palmar, Murcia, Espanha, 30120
        • Recrutamento
        • Hospital Clínico Universitario Virgen de Arrixaca
        • Contato:
          • Dr Ana Morales Ortiz
    • Sevilla
      • Seville, Sevilla, Espanha, 41009
        • Recrutamento
        • Hospital Universitario Virgen Macarena
        • Contato:
          • Soledad Pérez Sánchez
    • Tarragona
      • Tarragona, Tarragona, Espanha, 43005
        • Recrutamento
        • Hospital Universitari Joan XXIII
        • Contato:
          • Dr Xavier Ustrell Roig
  • Estados Unidos
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85719
    • California
      • Carmichael, California, Estados Unidos, 95608
        • Recrutamento
        • Mercy Medical Group
        • Contato:
          • Lucian Maidan, MD
      • Oxnard, California, Estados Unidos, 93030
        • Recrutamento
        • St. John's Regional Medical Center
        • Contato:
          • Mani Nezhad
    • Florida
      • Sarasota, Florida, Estados Unidos, 34239
        • Recrutamento
        • Sarasota Memorial Hospital
        • Contato:
          • Dr. Mauricio Concha
    • Georgia
      • Marietta, Georgia, Estados Unidos, 30060
        • Recrutamento
        • Wellstar Kennestone Hospital
        • Contato:
          • Dr. Ovais Inamullah
    • Missouri
      • Bridgeton, Missouri, Estados Unidos, 63044
        • Recrutamento
        • SSM Health Neurosciences
        • Contato:
          • Amer Alshekhlee, MD
    • New Jersey
      • Paramus, New Jersey, Estados Unidos, 07652
        • Recrutamento
        • Hackensack University Medical Center at Paramus
        • Contato:
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27514
        • Recrutamento
        • UNC Medical Center
        • Contato:
          • Dr. Ho, James
      • Greensboro, North Carolina, Estados Unidos, 27401
        • Recrutamento
        • Guilford Neurologic Associates Inc
        • Contato:
          • Dr. Pramod Sethi
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • OSU Wexner Medical Center
        • Contato:
          • Yousef Hannawi
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Recrutamento
        • UPMC Presbyterian Hospital
        • Contato:
          • Dr Jussie Correia Lima
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • Recrutamento
        • CHI Memorial Neuroscience Institute
        • Contato:
          • Thomas Devlin
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • Baylor College of Medicine
        • Contato:
          • Dr. Rao, Chethan
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • Memorial Hermann Hospital
        • Contato:
          • Mahan Shahrivari, MD
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • Houston Medical Neurological Institute
        • Contato:
          • David Chui, MD
  • Reino Unido
      • Harrow, Reino Unido, HA1 3UJ
        • Recrutamento
        • London North West University Healthcare NHS Trust - Northwick Park Hospital
        • Contato:
      • Newcastle, Reino Unido, NE1 4LP
        • Recrutamento
        • Hospitals NHS Foundation Trust - Royal Victoria Infirmary RVI
        • Contato:
          • Dr. Anand Dixit
      • Stoke-on-Trent, Reino Unido, ST4 6QG
    • Bury
      • Bury, Bury, Reino Unido, BL9 7TD
        • Recrutamento
        • Fairfield General Hospital
        • Contato:
          • Dr Narayanamoorthi Saravanan
    • London
      • London, London, Reino Unido, NW1 2BU
        • Recrutamento
        • National Hospital for Neurology & Neurosurgery
        • Contato:
          • Dr Richard Perry
      • London, London, Reino Unido, SE5 9RS
        • Recrutamento
        • King's College Hospital NHS Foundation Trust
        • Contato:
          • Dr Yee Mah
      • London, London, Reino Unido, SW17 0QT
    • Southampton
      • Southampton, Southampton, Reino Unido, SO16 6YD
        • Recrutamento
        • University Hospital Southampton
        • Contato:
          • Dr Richard Marigold
    • Wolverhampton
      • Wolverhampton, Wolverhampton, Reino Unido, WV10 0QP
        • Recrutamento
        • New Cross Hospital - Royal Wolverhampton NHS Trust
        • Contato:
          • Dr Nasar Ahmad

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Medicamento: 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.

Outros nomes:
  • Veículo
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.
Medicamento: Sovateltide

Phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.

Outros nomes:
  • PMZ-1620

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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.
Prazo: 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.
Prazo: 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 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.
Prazo: 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.
Prazo: Day 1 through Day 90

The proportion of patients with recurrent ischemic stroke within 90 days post-randomization.
Day 1 through Day 90
Determine the incidence of mortality within 90 days post-randomization.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: Day 1 through Day 90

The proportion of patients with adverse events (AEs) and serious adverse events (SAEs).
Day 1 through Day 90

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by mRS score of 0-2 at day 30 post-randomization.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pharmazz, Inc.

Investigadores

  • Cadeira de estudo: Anil Gulati, MD, PhD, Pharmazz, Inc.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de julho de 2025

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

11 de janeiro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de janeiro de 2023

Primeira postagem (Real)

19 de janeiro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Sovateltide/ACIS/IND2022

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

December 2027

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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