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This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

24. Mai 2022 aktualisiert von: Boehringer Ingelheim

A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.

The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure.

The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

19

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
      • Beijing, China, 100029
        • Beijing Anzhen Hospital
      • Beijing, China, 100037
        • Cardiovascular Institute and Fu Wai Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Dalian, China, 116011
        • First Affiliated Hospital of Dalian Medical University
      • Guangzhou, China, 510288
        • Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
      • Hangzhou, China, 310009
        • 2nd Affiliated Hosp Zhejiang University College of Medical
      • Hangzhou, China, 310014
        • Zhejiang Province People's Hospital
      • Nanchang, China, 330006
        • The Second Affiliated Hospital to Nanchang University
      • Nanjing, Jiangsu Province, China, 210029
        • Jiangsu Province Hospital
      • Shanghai, China, 200080
        • Shanghai First People's Hospital
      • Urumqi, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
      • Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Med College

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion criteria:

  • ≥ 18 years at screening.
  • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Currently taking dabigatran etexilate

  • They meet the following criteria:

    • Group A: Overt bleeding judged by the physician to require a reversal agent. OR
    • Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.

Exclusion criteria:

Group A:

  • Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
  • Patients with no clinical signs of bleeding.
  • Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Group B:

  • A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
  • Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group A - patients with uncontrolled or life-threatening bleeding
Arzneimittel: Idarucizumab
Intravenous
Andere Namen:
  • PRAXBIND, Praxbind, Prizbind
Experimental: Group B - patients not bleeding but requiring emergency surgery or invasive procedure
Arzneimittel: Idarucizumab
Intravenous
Andere Namen:
  • PRAXBIND, Praxbind, Prizbind

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
Zeitfenster: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.

Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported.

The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 41.26 seconds.
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time
Zeitfenster: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.

Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported.

The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 35.54 seconds.
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)
Zeitfenster: Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported.
Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery
Zeitfenster: Up to 24 hours post-surgery.
Number of participants with major bleeding (for Group B only) intra-operatively and up to 24 hours post-surgery per International Society for Thrombosis and Hemostasis (ISTH) classification is reported.
Up to 24 hours post-surgery.
Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)
Zeitfenster: Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.
Minimum unbound sum dabigatran concentrations since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1) is reported.
Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Zeitfenster: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.

Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported.

The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 39.80 seconds.
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)
Zeitfenster: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.

Maximum reversal of anticoagulation as measured by thrombin time (TT) is reported.

The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If calculated reversal is > 100, it was set to 100. 100% ULN is 14.22 seconds.
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Numbers of Participants With Any Adverse Events - on Treatment
Zeitfenster: Since the first infusion up until 5 days after the completion of the second infusion.
Numbers of participants with any adverse events during on treatment period is reported.
Since the first infusion up until 5 days after the completion of the second infusion.
Numbers of Participants With Any Adverse Events - Including Post Treatment Period
Zeitfenster: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Numbers of participants with any adverse events until end of study is reported.
Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Serious Adverse Events - on Treatment
Zeitfenster: Since the first infusion up until 5 days after the completion of the second infusion.
Number of participants with Serious adverse events during on treatment period is reported.
Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Serious Adverse Events - Including Post Treatment Period
Zeitfenster: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of participants with Serious adverse events until the end of study is reported.
Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Drug-related Adverse Events - on Treatment
Zeitfenster: Since the first infusion up until 5 days after the completion of the second infusion.
Numbers of patients with drug-related adverse events during on treatment period is reported.
Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Drug-related Adverse Events - Including Post Treatment Period
Zeitfenster: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Numbers of patients with drug-related adverse events until end of study is reported.
Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Immune Reaction Adverse Event - on Treatment
Zeitfenster: Since the first infusion up until 5 days after the completion of the second infusion.
Number of participants with immune reaction adverse event during on treatment period is reported.
Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period
Zeitfenster: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of participants with immune reaction adverse event until end of study is reported.
Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Thrombotic Events - on Treatment
Zeitfenster: Since the first infusion up until 5 days after the completion of the second infusion.
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported.
Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Thrombotic Events - Including Post Treatment Period
Zeitfenster: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported.
Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. März 2018

Primärer Abschluss (Tatsächlich)

2. Juli 2020

Studienabschluss (Tatsächlich)

2. Juli 2020

Studienanmeldedaten

Zuerst eingereicht

13. November 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. November 2017

Zuerst gepostet (Tatsächlich)

17. November 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juni 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Mai 2022

Zuletzt verifiziert

1. Mai 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1321-0019

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-Sharing-Zeitrahmen

After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD-Sharing-Zugriffskriterien

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Art der unterstützenden IPD-Freigabeinformationen

  • Studienprotokoll
  • Statistischer Analyseplan (SAP)
  • Klinischer Studienbericht (CSR)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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