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ARDS の成人患者におけるレパリキシンの追加

2026年5月8日 更新者：Dompé Farmaceutici S.p.A

急性呼吸窮迫症候群（RESPIRATIO）におけるSoCへの追加療法としてのレパリキシンの有効性と安全性を評価するための第2相、無作為化、二重盲検、プラセボ対照、多施設研究

研究目的

  1. 中等度から重度の ARDS (PaO2/FIO2 比 ≤ 200) の成人患者における肺損傷と全身性炎症の改善、および臨床的回復の促進と人工呼吸器からの解放におけるレパリキシンの有効性を特徴付ける。
  2. 研究に登録された患者におけるレパリキシンとプラセボの安全性を評価すること。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

第 2 相、無作為化、二重盲検、プラセボ対照、多施設試験。 すべての患者は、ARDS管理に関連する現在の標準治療に沿った治療を受けます（プロトコル化された人工呼吸器管理は、現在受け入れられている標準治療に従ってすべての施設で利用できるようになります）。 患者は、レパリキシンまたはプラセボのいずれかに無作為化 (1:1) されます。 治療期間は14日間です。

研究は4つの研究期間で構成されます。

スクリーニング無作為化およびベースライン評価、治療（14 日間、最長 21 日間の任意の延長）、フォローアップ（最長 28 日間または退院のいずれか早い方、その後 60 日目まで）。

研究の種類

介入

入学 (実際)

66

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  1. 現地のガイドラインおよび規制に従って、署名済みのインフォームド コンセント。
  2. 男性および女性の成人 (>18 歳)。
  3. PEEP が 5 cmH2O 以上で、PaO2/FIO2 比が 200 以下の人工呼吸器（侵襲的）患者。
  4. 心不全または体液過剰では十分に説明できない呼吸不全（臨床像の一部として急性うっ血性心不全の増悪が確認された場合は、患者が登録される前に効果的かつできるだけ早く対処する必要があります）。
  5. 胸部正面X線（CXR）で肺水腫と一致する両側の放射線学的陰影、または胸部コンピュータ断層撮影（CT）スキャンでの両側のスリガラス陰影。
  6. 上記の ARDS 基準を満たしてから 48 時間以内。
  7. 入院から7日以内。

  8. 性的に活動的な出産の可能性のある女性は、最後の治験薬（IMP）の投与後30日以内に妊娠しない意思があり、次の信頼できる避妊方法の少なくとも1つに同意する必要があります。

    1. -スクリーニング訪問の少なくとも2か月前から最後のIMP投与の30日後までのホルモン避妊、全身、埋め込み型、経皮、または注射可能な避妊薬;
    2. 無菌の性的パートナー;
    3. 禁欲。

-出産の可能性がない、または閉経後の状態にある女性参加者 少なくとも1年は認められます。 妊娠の可能性があるすべての女性被験者について、最初の薬物摂取前に妊娠検査結果が陰性でなければなりません。

除外基準:

  1. -中等度から重度の慢性肝疾患（関連する病歴、既存の場合は画像、およびChild-PughスコアB〜Cによって検証される）。
  2. 重度の慢性腎機能障害: eGFR (MDRD) < 30 mL/分/1.73m2 または腎代替療法の末期腎疾患。
  3. 別の介入臨床試験への参加。
  4. PIの推定に基づいて、今後24時間以内に死亡する可能性が高いと臨床的に判断された患者。
  5. 無酸素性脳損傷の証拠
  6. -現在、ECMOまたは高周波振動換気を受けています。
  7. -登録から24時間以内に予想される抜管。
  8. -活動性の悪性腫瘍（非メラニン性皮膚がんを除く）。
  9. -血行動態の不安定性（過去6時間の昇圧剤の> 30％増加またはノルエピネフリン> 0.5 mcg / Kg /分）。
  10. -例えば、急性膵炎または手術直後の状態による胃腸（GI）運動障害の証拠、持続的な胃の膨張、経腸栄養の不耐性、および/または持続的な胃の残留物> 500 ml）。
  11. -スクリーニングから72時間以内に予想される退院または別の病院への転院。
  12. 延命治療の差し控えまたは撤回の決定（ただし、心停止が発生した場合の心肺蘇生を除いて、患者が完全なサポートに専念している場合は、患者は依然として適格である可能性があります）。

  13. の歴史：

    1. -スルファメタジン、スルファメトキサゾール、スルファサラジン、ニメスリド、またはセレコキシブなどのスルホンアミドのクラスに属する複数の薬物に対するアレルギー/過敏症の記録（スルファニルアミド抗生物質のみに対する過敏症、例えば、スルファニルアミド抗生物質は除外対象ではありません）、および研究製品および／またはその賦形剤。
    2. ラクターゼ欠損症、ガラクトース血症またはグルコース-ガラクトース吸収不良。
    3. -以前の非ステロイド性抗炎症薬（NSAID）療法または再発性消化性潰瘍/出血による消化管出血または穿孔の病歴。
    4. イブプロフェンに過敏。
  14. -活動的な出血（月経を除く）または慢性的に高用量のNSAIDを服用している患者を含む出血素因。
  15. 妊娠中または授乳中の女性。
  16. -出産の可能性のある女性および妊娠可能な男性 研究中に少なくとも1つの主要な避妊法を使用することに同意せず、最後のIMP投与から最大30日後。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：レパリキシン + 標準治療
レパリキシン錠 1200 mg TID (2 錠 x 600 mg TID) を標準治療 (SoC) へのアドオンとして。
薬：レパリキシン 600mg
レパリキシン 600 mg 錠剤。標準治療への追加として、経鼻胃管を通して 1,200 mg TID の用量で粉砕して投与されます (約 8 時間ごとに 2 錠を TID 投与)。 抜管後、患者が嚥下できる場合には、レパリキシンを経口投与してもよい。 総治療期間: 14 日間
他の名前：
  • 担当者
プラセボコンパレーター：プラセボ + 標準治療
標準治療（SoC）へのアドオンとして、レパリキシンと同じスケジュールのプラセボ錠剤
他の：一致するプラセボ

プラセボ錠剤。 標準治療への追加として、レパリキシンと同じスケジュールで経鼻胃管を通して粉砕投与されます。 抜管後、患者が飲み込める場合には、プラセボを経口投与してもよい。

総治療期間: 14 日間

他の名前：
  • コントロール

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Oxygenation Index (OI) From Baseline to Day 4
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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

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スポンサー

Dompé Farmaceutici S.p.A

捜査官

  • 主任研究者：Moerer Onnen, MD、Universitaetsmedizin Goettingen

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年12月6日

一次修了 (実際)

2025年3月18日

研究の完了 (実際)

2025年4月18日

試験登録日

最初に提出

2022年8月4日

QC基準を満たした最初の提出物

2022年8月9日

最初の投稿 (実際)

2022年8月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月11日

QC基準を満たした最後の更新が送信されました

2026年5月8日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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