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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 maj 2022 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

19

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Group A - patients with uncontrolled or life-threatening bleeding
Läkemedel: Idarucizumab
Intravenous
Andra namn:
  • PRAXBIND, Praxbind, Prizbind
Experimentell: Group B - patients not bleeding but requiring emergency surgery or invasive procedure
Läkemedel: Idarucizumab
Intravenous
Andra namn:
  • PRAXBIND, Praxbind, Prizbind

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 mars 2018

Primärt slutförande (Faktisk)

2 juli 2020

Avslutad studie (Faktisk)

2 juli 2020

Studieregistreringsdatum

Först inskickad

13 november 2017

Först inskickad som uppfyllde QC-kriterierna

13 november 2017

Första postat (Faktisk)

17 november 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juni 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 maj 2022

Senast verifierad

1 maj 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1321-0019

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • Studieprotokoll
  • Statistisk analysplan (SAP)
  • Klinisk studierapport (CSR)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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