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Reparixina Complementar em Pacientes Adultos com SDRA

8 de maio de 2026 atualizado por: Dompé Farmaceutici S.p.A

Fase 2, Randomizado, Duplo-cego, Controlado por Placebo, Estudo Multicêntrico para Avaliar a Eficácia e Segurança da Reparixina como Terapia Complementar ao SoC na Síndrome do Desconforto Respiratório Agudo (RESPIRATIO)

Objetivos do estudo

  1. Caracterizar a eficácia da reparixina na melhora da lesão pulmonar e inflamação sistêmica e na aceleração da recuperação clínica e liberação da ventilação mecânica em pacientes adultos com SDRA moderada a grave (relação PaO2/FIO2 ≤ 200).
  2. Avaliar a segurança da reparixina versus placebo em pacientes incluídos no estudo.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Fase 2, randomizado, duplo-cego, controlado por placebo, estudo multicêntrico. Todos os pacientes receberão terapia de acordo com o padrão de atendimento atual no que se refere ao gerenciamento de SDRA (o gerenciamento do ventilador protocolado será disponibilizado para todos os locais de acordo com o padrão de atendimento atualmente aceito). Os pacientes serão randomizados (1:1) para reparixina ou placebo. A duração do tratamento será de 14 dias.

O estudo consistirá em 4 períodos de estudo:

Triagem Randomização e avaliações iniciais, Tratamento (14 dias com extensão discricionária até 21 dias), Acompanhamento (até 28 dias ou alta hospitalar, o que ocorrer primeiro, e depois até o dia 60).

Tipo de estudo

Intervencional

Inscrição (Real)

66

Estágio

  • Fase 2

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.

Locais de estudo

  • Alemanha
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Alemanha, 69120
        • Universitaetsklinikum Heidelberg
    • Lower Saxony
      • Göttingen, Lower Saxony, Alemanha, 37075
        • Universitaetsmedizin Goettingen
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Alemanha, 48149
        • Herzzentrum Muenster
    • Saxony
      • Leipzig, Saxony, Alemanha, 4103
        • Universitaetsklinikum Leipzig
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Alemanha, 6112
        • Berufsgenossenschaftliche Kliniken Bergmannstrost
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Alemanha, 24105
        • University Hospital of Schleswig-Holstein
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • The University of Alabama at Birmingham Hospital
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85006
        • Banner - University Medical Center Phoenix
    • California
      • Los Angeles, California, Estados Unidos, 90033
        • University of Southern California
      • Orange, California, Estados Unidos, 92868
        • University of California Irvine Health
      • Sacramento, California, Estados Unidos, 95817
        • Unversity of California Davis Medical Center
    • Colorado
      • Denver, Colorado, Estados Unidos, 80204
        • Denver Health
    • Florida
      • Tampa, Florida, Estados Unidos, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Emory Saint Joseph's Hospital
    • Indiana
      • Gary, Indiana, Estados Unidos, 46404
        • Methodist Hospitals of Northwest Indiana
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center
      • Newton, Massachusetts, Estados Unidos, 02462-1607
        • Newton Wellesley Hospital
      • Springfield, Massachusetts, Estados Unidos, 01107
        • Baystate Health
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Estados Unidos, 48201
        • Detroit Medical Center
      • Midland, Michigan, Estados Unidos, 48670
        • MyMichigan Medical Center Midland
      • Royal Oak, Michigan, Estados Unidos, 48073
        • William Beaumont Hospital
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39202
        • Jackson Pulmonary Associates
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65212
        • University of Missouri Health Care
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Hackensack Meridian Health
    • New York
      • Brooklyn, New York, Estados Unidos, 11220
        • NYU Langone Brooklyn
      • New York, New York, Estados Unidos, 10016
        • New York University Langone Health
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, Estados Unidos, 43210
        • The Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • University of Oklahoma Medical Center
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37920
        • University of Tennessee Medical Center
    • Texas
      • Beaumont, Texas, Estados Unidos, 77701
        • Baptist Hospitals of Southeast Texas
      • Dallas, Texas, Estados Unidos, 75390-8894
        • University of Texas Southwestern Medical Center
      • Denison, Texas, Estados Unidos, 75020
        • CardioVoyage
      • Houston, Texas, Estados Unidos, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84108
        • University of Utah Hospitals & Clinics
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298
        • Virginia Commonwealth University Health System
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin
  • Itália
    • Lombardy
      • Milan, Lombardy, Itália, 20132
        • Ospedale San Raffaele

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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  1. Termo de Consentimento Livre e Esclarecido assinado, de acordo com as diretrizes e regulamentos locais.
  2. Adultos masculinos e femininos (>18 anos).
  3. Pacientes ventilados mecanicamente (invasivos) com relação PaO2/FIO2 ≤200 na presença de PEEP ≥5 cmH20.
  4. Insuficiência respiratória não totalmente explicada por insuficiência cardíaca ou sobrecarga de fluidos (se a exacerbação aguda da Insuficiência Cardíaca Congestiva for identificada como parte do quadro clínico, isso deve ser tratado de forma eficaz e o mais rápido possível antes que o paciente possa ser inscrito).
  5. Opacidades radiológicas bilaterais consistentes com edema pulmonar na radiografia de tórax frontal (RX), ou opacidades bilaterais em vidro fosco em uma tomografia computadorizada (TC) de tórax.
  6. ≤48 horas após o cumprimento dos critérios de SDRA acima.
  7. ≤ 7 dias a partir da admissão hospitalar.

  8. Mulheres com potencial para engravidar e sexualmente ativas devem estar dispostas a não engravidar dentro de 30 dias após a última dose do Medicamento Experimental (PIM) e devem concordar com pelo menos um dos seguintes métodos confiáveis ​​de contracepção:

    1. Contracepção hormonal, anticoncepcionais sistêmicos, implantáveis, transdérmicos ou injetáveis ​​de pelo menos 2 meses antes da visita de triagem até 30 dias após a última dose de IMP;
    2. Um parceiro sexual estéril;
    3. Abstinência.

Participantes do sexo feminino sem potencial para engravidar ou em estado pós-menopausa por pelo menos 1 ano serão admitidas. Para todas as mulheres com potencial para engravidar, o resultado do teste de gravidez deve ser negativo antes da primeira ingestão do medicamento.

Critério de exclusão:

  1. Doença hepática crônica moderada a grave (conforme verificado por história relevante, exames de imagem, se pré-existentes, e escore de Child-Pugh B-C).
  2. Disfunção renal crônica grave: eGFR (MDRD) < 30 mL/min/1,73m2 ou Doença Renal Terminal em terapia de substituição renal.
  3. Participação em outro ensaio clínico intervencionista.
  4. Pacientes clinicamente determinados como tendo alta probabilidade de morte nas próximas 24 horas com base na estimativa do PI.
  5. Evidência de lesão cerebral anóxica
  6. Atualmente recebendo ECMO ou ventilação oscilatória de alta frequência.
  7. Extubação antecipada dentro de 24 horas após a inscrição.
  8. Malignidade ativa (com exceção dos cânceres de pele não melanóticos).
  9. Instabilidade hemodinâmica (aumento >30% do vasopressor nas últimas 6 horas ou norepinefrina > 0,5 mcg/Kg/min).
  10. Evidência de dismotilidade gastrointestinal (GI), por exemplo, devido a pancreatite aguda ou estado pós-operatório imediato, conforme demonstrado por distensão gástrica persistente, intolerância à alimentação enteral e/ou resíduos gástricos persistentes > 500 ml).
  11. Alta hospitalar antecipada ou transferência para outro hospital em até 72 horas após a triagem.
  12. Decisão de suspender ou suspender o tratamento de suporte à vida (os pacientes ainda podem ser elegíveis, no entanto, se estiverem comprometidos com suporte total, exceto ressuscitação cardiopulmonar, se ocorrer parada cardíaca).

  13. História de:

    1. Alergia/hipersensibilidade documentada a mais de um medicamento pertencente à classe das sulfonamidas, como sulfametazina, sulfametoxazol, sulfassalazina, nimesulida ou celecoxibe (hipersensibilidade apenas a antibióticos sulfanilamida, por exemplo, sulfametoxazol não se qualifica para exclusão) e ao produto do estudo e /ou seus excipientes.
    2. Deficiência de lactase, galactosemia ou má absorção de glicose-galactose.
    3. História de sangramento ou perfuração gastrointestinal devido a terapia anterior com anti-inflamatórios não esteróides (AINEs) ou úlcera/hemorragia péptica recorrente.
    4. Hipersensibilidade ao ibuprofeno.
  14. Sangramento ativo (excluindo menstruação) ou diátese hemorrágica, incluindo pacientes em uso crônico de altas doses de AINEs.
  15. Mulheres grávidas ou lactantes.
  16. Mulheres com potencial para engravidar e homens férteis que não concordem em usar pelo menos uma forma primária de contracepção durante o estudo e até 30 dias após a última dose de IMP.

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
Experimental: Reparixina + Padrão de cuidado
Reparixin comprimidos 1200 mg TID (2 comprimidos x 600 mg TID) como complemento ao tratamento padrão (SoC).
Medicamento: Reparixina 600mg
Comprimidos de Reparixin 600 mg, administrados esmagados através de sonda nasogástrica na dose de 1200 mg três vezes por dia (2 comprimidos três vezes por dia administrados aproximadamente a cada 8 horas) como complemento ao tratamento padrão. Após a extubação e se o paciente conseguir engolir, a reparixina pode ser administrada por via oral. Duração total do tratamento: 14 dias
Outros nomes:
  • REP
Comparador de Placebo: Placebo + Padrão de cuidado
Comprimidos placebo com o mesmo esquema de reparixina, como complemento ao tratamento padrão (SoC)
Outro: Placebo correspondente

Comprimidos placebo. Administrado triturado por sonda nasogástrica com o mesmo esquema da reparixina como complemento ao tratamento padrão. Após a extubação e se o paciente conseguir engolir, o placebo pode ser administrado por via oral.

Duração total do tratamento: 14 dias

Outros nomes:
  • Ao controle

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
Prazo: Baseline to Day 7
Oxygenation Index is defined as Mean Airway Pressure multiplied by (Fraction of Inspired Oxygen[FiO2]) x (100)/(Partial Pressure of Oxygen[PaO2]). It is a measure of efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. Baseline was defined as last measurement collected prior to investigational medicinal product intake. Change from baseline was defined as post-baseline assessment minus baseline value. Adjusted means and 95% confidence interval from an ANOVA model with multiple imputation (MI) for missing data have been presented.
Baseline to Day 7
Ventilator-Free Days (VFD)
Prazo: At Day 28
Ventilator free days (VFDs) through Day 28 were defined as the number of days from the first IMP intake during which the participant was alive and free of invasive mechanical ventilation. Participants who died before or at Day 28 were assigned a value of 0 ventilator-free days, in accordance with the estimand definition. Adjusted means and 95% confidence interval from an ANOVA model with MI for missing data have been presented.
At Day 28

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Oxygenation Index (OI) From Baseline to Day 4
Prazo: Baseline to Day 4
Oxygenation Index (OI) is defined as Mean Airway Pressure multiplied by (FiO2) x (100) / (PaO2). It is a measure of the efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to the estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. For Day 4, no imputation or adjusted means were applied; only observed data from participants with available measurements were used. Baseline was defined as the last measurement collected prior to IMP intake. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline to Day 4
Change From Baseline of Acute Lung Injury (ALI) Score
Prazo: Baseline and at Days 2, 3, 7 and 14
Acute Lung Injury (ALI) Score is a composite 4-point scoring system validated by the National Heart, Lung, and Blood Institute (NHLBI) acute respiratory distress syndrome (ARDS) Network that considers PaO2/FiO2, the level of positive end-expiratory pressure (PEEP), lung/respiratory compliance [plateau airway pressure minus PEEP/Tidal Volume (TV)], and the extent of pulmonary infiltrates on the chest radiograph. Each criterion was scored from 0-4 based on the severity of the condition. The final score was calculated by dividing the total score by the number of criteria used. A score of 0 indicates no lung injury, a score between 0.1 to 2.5 indicates mild to moderate lung injury and a score of >2.5 indicates severe lung injury (ARDS). Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Change From Baseline of Sequential Organ Failure Assessment (SOFA) Score
Prazo: Baseline and at Days 2, 3, 7 and 14
The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). The score ranges for each system organ classes range from 0 to 4. SOFA score was calculated every 24 hours using (for each organ system) the worst variable recorded within the same 24 hours. The best possible score corresponds to 0 whereas the worst score corresponds to 24. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Change From Baseline of Ventilatory Ratio
Prazo: Baseline and at Days 2, 3, 7 and 14

The Ventilatory Ratio (VR) is a simple, non-invasive bedside index used to monitor the efficiency of carbon dioxide (CO2) clearance in mechanically ventilated participants, particularly those with ARDS.

VR = [minute ventilation (ml/min) × PaCO2 (mm Hg)] / [predicted body weight × 100 (ml/min) × 37.5 (mm Hg)] VR is a unitless ratio, and a value approximating 1 would represent normal ventilating lungs. An elevated value of VR would represent either increased pulmonary dead space, increased VCO2 or both. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Number of Participants Requiring Extracorporeal Membrane Oxygenation (ECMO) at Day 14
Prazo: At Day 14
Extracorporeal Membrane Oxygenation (ECMO) is an advanced form of temporary life support used for participants with life-threatening heart or lung failure that has not responded to conventional treatments. It functions as a modified heart-lung bypass machine, circulating blood outside the body to add oxygen and remove carbon dioxide before returning it to the participants. Use of ECMO between first investigational medicinal product intake and Day 14 was counted.
At Day 14
Percentage of Participants Using Vasoactive Medications at Day 14
Prazo: At Day 14
Use of vasoactive medication is defined as the percentage of participants who received ≥1 vasoactive medication at any time from first IMP intake (Day 1) up to and including Day 14 (inclusive window), divided by the number of participants in the analysis population. Use of Vasoactive Medications is collected in "Ventilation - Specific Information" CRF Daily assessments through extubation. An event is recorded as "Yes" if vasoactive medication use is reported at any daily assessment performed between the date/time of first IMP intake (Day 1) and Day 14 (Day 1 + 13 days), inclusive. If no use is reported during this period, the event is recorded as "No" provided the last available assessment occurs on or after Day 12 (allowing a ±2-day window for the Day 14 visit). The event is recorded as missing if the last available assessment occurs before Day 12.
At Day 14
Change From Baseline of Chest X-ray (CXR) Assessment of Pulmonary Edema by Radiographic Assessment of Lung Edema (RALE) Score
Prazo: Baseline and at Days 2, 3, 7 and 14
Radiographic Assessment of Lung Edema (RALE) score is a validated, semi-quantitative tool for quantifying pulmonary edema and ARDS severity using chest X-rays (CXR). It is calculated by dividing the lung fields on the chest radiograph into four quadrants. Each quadrant was assigned a number, and the extent of alveolar opacities (the consolidation score, from 0 to 4) and density of alveolar opacities (the density score, from 1 to 3) was determined. If the consolidation score was 0, the density score was 0. The final RALE score was the sum of the product of the consolidation and density score for each quadrant. Thus, the final RALE score ranged from minimum 0 to maximum 48. Higher RALE scores indicate more severe edema and poorer outcomes. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Baseline and at Days 2, 3, 7 and 14
Percentage of Participants Achieving Pressure Support Ventilation Equal to 5 cm H20 With PEEP Equal to 5 cm H20 for 2 Hours (Measure of Weaning)
Prazo: At Day 28 and Hospital Discharge (Up to Day 30)
Continuous Positive Airway Pressure (CPAP) is defined as use of pressure support ventilation equal to 5 cmH2O with PEEP equal to 5 cmH2O for 2 hours. Each qualifying CPAP trial recorded in the Ventilation Specific Information CRF is counted as one weaning attempt. By Day 28: An event is recorded as "Yes" if at least one CPAP weaning attempt (>0) is reported between Day 1 (first IMP intake) and Day 28 (Day 1 + 27 days). The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. By Hospital Discharge: An event is recorded as "Yes" if at least one CPAP weaning attempt (>0) is reported between Day 1 and hospital discharge. The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. Hospital discharge date is obtained from EOS or, if missing, from the Hospital Discharge visit date; if unavailable, hospitalization is assumed ongoing.
At Day 28 and Hospital Discharge (Up to Day 30)
Intensive Care Unit (ICU)-Free Days
Prazo: At Day 28 and Hospital Discharge (Up to Day 30)
Intensive Care Unit (ICU) free days were defined as number of calendar days from first IMP intake during which a participant was alive and not hospitalized in an ICU. ICU-free days at Day 28 were calculated as 28 minus total number of ICU days up to Day 28, with negative values set to 0. Participants who died on or before Day 28 were assigned 0 ICU-free days. If a participant was discharged before Day 28 and died after discharge but before Day 28, ICU-free days at Day 28 equaled ICU-free days at discharge. Endpoint was set to missing if participant was alive but followed for fewer than 26 days or if required data were missing. ICU-free days at hospital discharge were calculated as (discharge date - first IMP intake date + 1) minus total ICU days up to discharge, with negative values set to 0. Participants who died during hospitalization were assigned 0 ICU-free days. If discharge did not occur and death occurred after Day 28, ICU-free days at discharge equaled ICU-free days at Day 28.
At Day 28 and Hospital Discharge (Up to Day 30)
Hospital-free Days
Prazo: Up to Day 28
Hospital-free days are a participant-centered metric defining the number of days a participant stays alive outside an acute-care hospital. If the participant was alive at Day 28 (last available day ≥26), hospital-free days were calculated as 28 minus total hospital days up to Day 28. If the participant died on or before Day 28, hospital-free days were set to 0.
Up to Day 28
Percentage of Participants With Tracheostomies
Prazo: At Day 28 and Hospital Discharge (Up to Day 30)
Percentage of participants who underwent a tracheostomy between Day 1 and Day 28 or hospital discharge, has been presented. The event is recorded as "Yes" if a tracheostomy occurred during this period, "No" if no procedure occurred and the visit/discharge date is available and missing if both the procedure date and visit/discharge date are unavailable.
At Day 28 and Hospital Discharge (Up to Day 30)
Percentage of Participants Transferred to a Long-Term Acute Care (LTAC) Facility
Prazo: From Day 1 of first IMP intake through Day 28 and Hospital Discharge (Up to Day 30)
An LTAC is a Long Term Acute Care Hospital, a facility that specializes in the treatment of participants with serious medical conditions, including patients with ongoing needs for mechanical ventilation, but who no longer require intensive care or extensive diagnostic procedures. The participants in LTAC are transferred there directly from the intensive care unit because they require more care than they can receive in a rehabilitation center, skilled care facility or at home.
From Day 1 of first IMP intake through Day 28 and Hospital Discharge (Up to Day 30)
Percentage of Participants Who Died by Day 28 and Day 60
Prazo: Up to Day 28 and 60
Percentage of death by Day 28 and Day 60 has been reported. The event is recorded as "Yes" if death occurred within the period, "No" if the participant was alive with last available assessment at or beyond Day 28 or Day 60.
Up to Day 28 and 60
Hospital Discharge by Day 28
Prazo: Day 28
A participant was considered discharged alive by Day 28 if hospital discharge occurred on or before Day 28, regardless of vital status after discharge. Participants were considered not discharged alive by Day 28 if they died without a recorded discharge date, were discharged after Day 28, had a missing discharge date with sufficient follow-up (last available day ≥26), or had a discharge date equal to the date of death. The endpoint was set to missing if the discharge date was missing and the participant was alive but followed for fewer than 26 days. Percentage of participants discharged from hospital by Day 28 has been presented.
Day 28
Change From Baseline in Plasma Biomarkers: Interleukin-6 (IL-6), IL-8, and Plasma Tumor Necrosis Factor Receptor 1 (TNFr-1)
Prazo: Baseline and at Days 3, 7 and 14
Plasma biomarker levels for Interleukin -6 (IL-6), IL-8 and plasma Tumor Necrosis Factor Receptor 1 (TNFr-1) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
Baseline and at Days 3, 7 and 14
Change From Baseline in Plasma Biomarkers: PAI-1, ICAM-1, and RAGE
Prazo: Baseline and at Days 3, 7 and 14
Plasma biomarker levels of plasminogen activator inhibitor-1 (PAI-1), intercellular adhesion molecule-1 (ICAM-1), and receptor for advanced glycation end products (RAGE) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
Baseline and at Days 3, 7 and 14
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (Serious TEAEs)
Prazo: Up to 26 Months
An Adverse Event (AE) is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention. A TEAE is defined as any untoward medical occurrence that begins or worsens in intensity or frequency after the initiation of a treatment (e.g., drug, device, or procedure) in a clinical study. A Serious TEAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization.
Up to 26 Months

Colaboradores e Investigadores

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

Patrocinador

Dompé Farmaceutici S.p.A

Investigadores

  • Investigador principal: Moerer Onnen, MD, Universitaetsmedizin Goettingen

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)

6 de dezembro de 2022

Conclusão Primária (Real)

18 de março de 2025

Conclusão do estudo (Real)

18 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

4 de agosto de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de agosto de 2022

Primeira postagem (Real)

11 de agosto de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • REP0122
  • 2022-001612-25 (Número EudraCT)

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

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