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Add-on Reparixin hos voksne pasienter med ARDS

8. mai 2026 oppdatert av: Dompé Farmaceutici S.p.A

Fase 2, randomisert, dobbeltblindet, placebokontrollert, multisenterstudie for å vurdere effektiviteten og sikkerheten til Reparixin som tilleggsterapi til SoC ved akutt respiratorisk distresssyndrom (RESPIRATIO)

Studiemål

  1. Å karakterisere effekten av reparixin for å lindre lungeskade og systemisk betennelse og fremskynde klinisk utvinning og frigjøring fra mekanisk ventilasjon hos voksne pasienter med moderat til alvorlig ARDS (PaO2/FIO2-forhold ≤ 200).
  2. For å evaluere sikkerheten til reparixin vs. placebo hos pasienter som er inkludert i studien.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Fase 2, randomisert, dobbeltblindet, placebokontrollert, multisenterstudie. Alle pasienter vil motta terapi i tråd med gjeldende behandlingsstandard når det gjelder ARDS-behandling (protokollisert respiratorbehandling vil bli gjort tilgjengelig for alle steder i samsvar med gjeldende standard for omsorg). Pasientene vil bli randomisert (1:1) til enten reparixin eller placebo. Behandlingsvarigheten vil være 14 dager.

Studiet vil bestå av 4 studieperioder:

Screening Randomisering og Baseline-vurderinger, Behandling (14 dager med skjønnsmessig forlengelse inntil 21 dager), Oppfølging (opptil 28 dager eller sykehusutskrivning, avhengig av hva som inntreffer først, og deretter opp til dag-60).

Studietype

Intervensjonell

Registrering (Faktiske)

66

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. Signert informert samtykke, i henhold til lokale retningslinjer og forskrifter.
  2. Mannlige og kvinnelige voksne (>18 år).
  3. Mekanisk ventilerte (invasive) pasienter med PaO2/FIO2-forhold ≤200 i nærvær av PEEP på ≥5 cmH20.
  4. Respirasjonssvikt er ikke fullt ut forklart av hjertesvikt eller væskeoverbelastning (hvis akutt forverring av kongestiv hjertesvikt er identifisert som en del av det kliniske bildet, bør dette behandles effektivt og så snart som mulig før pasienten kan innskrives).
  5. Bilaterale radiologiske opasiteter forenlig med lungeødem på frontal thorax røntgen (CXR), eller bilaterale slipte glassopasiteter på en CT-skanning av brystet.
  6. ≤48 timer fra oppfyllelse av ARDS-kriteriene ovenfor.
  7. ≤7 dager fra sykehusinnleggelse.

  8. Kvinner i fertil alder som er seksuelt aktive, må være villige til ikke å bli gravide innen 30 dager etter siste dose med undersøkelsesmedisin (IMP) og må godta minst én av følgende pålitelige prevensjonsmetoder:

    1. Hormonell prevensjon, systemiske, implanterbare, transdermale eller injiserbare prevensjonsmidler fra minst 2 måneder før screeningbesøket til 30 dager etter siste IMP-dose;
    2. En steril seksuell partner;
    3. Avholdenhet.

Kvinnelige deltakere med ikke-fertil alder eller i postmenopausal status i minst 1 år vil bli tatt opp. For alle kvinnelige forsøkspersoner med fertil alder må resultatet av graviditetstesten være negativ før første legemiddelinntak.

Ekskluderingskriterier:

  1. Moderat alvorlig kronisk leversykdom (som bekreftet av relevant historie, bildediagnostikk, hvis eksisterende, og Child-Pugh score B-C).
  2. Alvorlig kronisk nyresvikt: eGFR (MDRD) < 30 ml/min/1,73 m2 eller End Stage Renal Disease på nyreerstatningsterapi.
  3. Deltakelse i en annen intervensjonell klinisk studie.
  4. Pasienter som er klinisk fastslått å ha høy sannsynlighet for død i løpet av de neste 24 timene basert på PIs estimering.
  5. Bevis på anoksisk hjerneskade
  6. Mottar for tiden ECMO eller høyfrekvent oscillerende ventilasjon.
  7. Forventet ekstubering innen 24 timer etter påmelding.
  8. Aktiv malignitet (med unntak av ikke-melanotiske hudkreft).
  9. Hemodynamisk ustabilitet (>30 % økning i vasopressor siste 6 timer eller noradrenalin > 0,5 mcg/Kg/min).
  10. Bevis på gastrointestinal (GI) dysmotilitet, f.eks. på grunn av akutt pankreatitt eller umiddelbar postoperativ tilstand, som vist ved vedvarende gastrisk distensjon, enteral ernæringsintolerbarhet og/eller vedvarende gastriske rester >500 ml).
  11. Forventet utskrivning fra sykehuset eller overføring til annet sykehus innen 72 timer etter screening.
  12. Beslutning om å holde tilbake eller trekke tilbake livsopprettholdende behandling (pasienter kan likevel være kvalifisert hvis de er forpliktet til full støtte bortsett fra hjerte-lunge-redning hvis hjertestans oppstår).

  13. Historien om:

    1. Dokumentert allergi/overfølsomhet overfor mer enn ett medikament som tilhører klassen sulfonamider, slik som sulfametazin, sulfametoksazol, sulfasalazin, nimesulid eller celecoxib (overfølsomhet overfor sulfanilamidantibiotika alene, f.eks. sulfametoksazol, kvalifiserer ikke for studien og ekskluderer ikke studien) /eller dets hjelpestoffer.
    2. Laktasemangel, galaktosemi eller glukose-galaktose malabsorpsjon.
    3. Anamnese med GI-blødning eller -perforasjon på grunn av tidligere behandling med ikke-steroide antiinflammatoriske legemidler (NSAIDs) eller tilbakevendende magesår/blødning.
    4. Overfølsom overfor ibuprofen.
  14. Aktiv blødning (unntatt menstruasjon) eller blødende diatese inkludert pasienter på kronisk høye doser av NSAIDs.
  15. Gravide eller ammende kvinner.
  16. Kvinner i fertil alder og fertile menn som ikke godtar å bruke minst én primær prevensjonsform under studien og inntil 30 dager etter siste IMP-dose.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Reparixin + Standard for omsorg
Reparixin tabletter 1200 mg TID (2 tabletter x 600 mg TID) som tillegg til standarden for omsorg (SoC).
Legemiddel: Reparixin 600mg
Reparixin 600 mg tabletter, administrert knust gjennom nasogastrisk sonde i dosen 1200 mg TID (2 tabletter TID administrert omtrent hver 8. time) som tillegg til standarden for omsorg. Etter ekstubering og hvis pasienten kan svelge, kan reparixin gis oralt. Total behandlingsvarighet: 14 dager
Andre navn:
  • REP
Placebo komparator: Placebo + standard for omsorg
Placebotabletter med samme tidsplan for reparixin, som tillegg til standardbehandlingen (SoC)
Annen: Matchende placebo

Placebotabletter. Administrert knust gjennom nasogastrisk sonde med samme tidsplan som reparixin som tillegg til standardbehandlingen. Etter ekstubering og hvis pasienten kan svelge, kan placebo gis oralt.

Total behandlingsvarighet: 14 dager

Andre navn:
  • Styre

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Oxygenation Index (OI) From Baseline to Day 4
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dompé Farmaceutici S.p.A

Etterforskere

  • Hovedetterforsker: Moerer Onnen, MD, Universitaetsmedizin Goettingen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. desember 2022

Primær fullføring (Faktiske)

18. mars 2025

Studiet fullført (Faktiske)

18. april 2025

Datoer for studieregistrering

Først innsendt

4. august 2022

Først innsendt som oppfylte QC-kriteriene

9. august 2022

Først lagt ut (Faktiske)

11. august 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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