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ARDS가 있는 성인 환자의 레파리신 추가

2026년 5월 8일 업데이트: Dompé Farmaceutici S.p.A

급성 호흡곤란 증후군(RESPIRATIO)에서 SoC에 대한 추가 요법으로서 레파릭신의 효능 및 안전성을 평가하기 위한 2상, 무작위, 이중 맹검, 위약 대조, 다기관 연구

연구 목표

  1. 중등도에서 중증 ARDS(PaO2/FIO2 비율 ≤ 200)가 있는 성인 환자의 폐 손상 및 전신 염증을 개선하고 임상적 회복을 촉진하고 기계적 환기로부터 해방하는 레파릭신의 효능을 특성화합니다.
  2. 연구에 등록된 환자에서 레파릭신 대 위약의 안전성을 평가하기 위함.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

2상, 무작위, 이중 맹검, 위약 대조, 다기관 연구. 모든 환자는 ARDS 관리와 관련하여 현재 치료 표준에 따라 치료를 받게 됩니다(프로토콜화된 인공호흡기 관리는 현재 허용되는 치료 표준에 따라 모든 현장에서 사용할 수 있습니다). 환자는 레파릭신 또는 위약에 무작위 배정됩니다(1:1). 치료 기간은 14일입니다.

이 연구는 4개의 연구 기간으로 구성됩니다.

선별 무작위화 및 기준선 평가, 치료(최대 21일까지 재량에 따라 연장된 14일), 후속 조치(최대 28일 또는 병원 퇴원 중 먼저 발생한 후 최대 60일까지).

연구 유형

중재적

등록 (실제)

66

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  1. 지역 지침 및 규정에 따라 서명된 사전 동의.
  2. 성인 남성 및 여성(>18세).
  3. PaO2/FIO2 비율이 ≤200이고 PEEP가 ≥5 cmH20인 기계 환기(침습) 환자.
  4. 심부전 또는 체액 과부하로 완전히 설명되지 않는 호흡 부전(급성 울혈성 심부전 악화가 임상 양상의 일부로 확인되는 경우 이는 환자를 등록하기 전에 가능한 한 빨리 효과적으로 해결해야 합니다).
  5. 전면 흉부 X-레이(CXR)에서 폐부종과 일치하는 양측 방사선 혼탁 또는 흉부 전산화 단층 촬영(CT) 스캔에서 양측 간 유리 혼탁.
  6. 위의 ARDS 기준을 충족한 후 48시간 이하.
  7. 입원일로부터 7일 이내.

  8. 성적으로 왕성한 가임 여성은 마지막 IMP(Investigational Medicinal Product) 투여 후 30일 이내에 임신하지 않으려고 해야 하며 다음의 신뢰할 수 있는 피임 방법 중 하나 이상에 동의해야 합니다.

    1. 스크리닝 방문 최소 2개월 전부터 마지막 ​​IMP 투약 후 30일까지 호르몬 피임, 전신, 이식형, 경피 또는 주사형 피임제;
    2. 불임 성 파트너;
    3. 절제.

임신 가능성이 없거나 최소 1년 동안 폐경기 상태인 여성 참가자가 입장할 수 있습니다. 가임 가능성이 있는 모든 여성 피험자의 경우 첫 약물 복용 전에 임신 테스트 결과가 음성이어야 합니다.

제외 기준:

  1. 중등도-중증 만성 간 질환(관련 병력, 이미 존재하는 경우 영상 촬영 및 Child-Pugh 점수 B-C로 확인됨).
  2. 중증 만성 신기능 장애: eGFR (MDRD) < 30 mL/min/1.73m2 또는 신장 대체 요법에 대한 말기 신장 질환.
  3. 다른 중재 임상 시험에 참여.
  4. 임상적으로 PI의 추정에 따라 향후 24시간 이내에 사망할 가능성이 높다고 판단되는 환자.
  5. 무산소성 뇌 손상의 증거
  6. 현재 ECMO 또는 고주파 진동 인공호흡을 받고 있습니다.
  7. 등록 후 24시간 이내에 예상되는 발관.
  8. 활동성 악성 종양(비흑색성 피부암 제외).
  9. 혈역학적 불안정성(지난 6시간 동안 승압제의 >30% 증가 또는 노르에피네프린 > 0.5 mcg/Kg/min).
  10. 예를 들어 급성 췌장염 또는 수술 직후 상태로 인한 위장(GI) 운동 장애의 증거(지속적인 위 팽만, 장관 섭식 불내성 및/또는 지속적인 위 잔류 >500ml).
  11. 선별검사 후 72시간 이내에 퇴원 또는 다른 병원으로의 이송이 예상되는 경우.
  12. 연명 치료 보류 또는 철회 결정(심정지 발생 시 심폐소생술을 제외하고 완전한 지원을 약속하는 경우 환자는 여전히 자격이 있을 수 있음).

  13. 의 역사:

    1. 설파메타진, 설파메톡사졸, 설파살라진, 니메술리드 또는 셀레콕시브와 같은 설폰아미드 부류에 속하는 하나 이상의 약물에 대한 문서화된 알레르기/과민성(설파닐아미드 항생제 단독에 대한 과민성, 예를 들어, 설파메톡사졸은 배제 대상이 아님), 및 연구 제품 및 /또는 그 부형제.
    2. 락타아제 결핍, 갈락토스혈증 또는 포도당-갈락토스 흡수 장애.
    3. 이전의 비스테로이드성 항염증제(NSAIDs) 요법 또는 재발성 소화성 궤양/출혈로 인한 위장관 출혈 또는 천공의 병력.
    4. 이부프로펜에 과민합니다.
  14. 활동성 출혈(월경 제외) 또는 NSAID를 만성 고용량 투여 중인 환자를 포함한 출혈 체질.
  15. 임산부 또는 수유부.
  16. 연구 기간 동안 그리고 마지막 IMP 투여 후 최대 30일까지 적어도 하나의 기본 피임법을 사용하는 데 동의하지 않는 가임 여성 및 가임 남성.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 레파리신 + 치료 기준
Reparixin 정제 1200mg TID(정제 2개 x 600mg TID)를 표준 치료(SoC)에 추가합니다.
의약품: 레파릭신 600mg
레파릭신 600mg 정제는 표준 치료에 추가로 1200mg TID(대략 8시간마다 2정 TID 투여) 용량으로 비위관을 통해 분쇄하여 투여됩니다. 발관 후 환자가 삼킬 수 있으면 레파릭신을 경구 투여할 수 있습니다. 총 치료 기간: 14일
다른 이름들:
  • 대표
위약 비교기: 위약 + 표준 치료
동일한 일정의 레파릭신을 포함하는 위약 정제, 표준 치료(SoC)에 대한 추가 기능
다른: 위약 매칭

위약 정제. 표준 치료에 추가로 레파릭신과 동일한 일정으로 비위관을 통해 분쇄하여 투여합니다. 발관 후 환자가 삼킬 수 있는 경우 위약을 경구 투여할 수 있습니다.

총 치료 기간: 14일

다른 이름들:
  • 제어

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Oxygenation Index (OI) From Baseline to Day 4
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Dompé Farmaceutici S.p.A

수사관

  • 수석 연구원: Moerer Onnen, MD, Universitaetsmedizin Goettingen

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 12월 6일

기본 완료 (실제)

2025년 3월 18일

연구 완료 (실제)

2025년 4월 18일

연구 등록 날짜

최초 제출

2022년 8월 4일

QC 기준을 충족하는 최초 제출

2022년 8월 9일

처음 게시됨 (실제)

2022년 8월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 8일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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