Value through Innovation27 July 2016

Clinical Study Results

  • PRAXBIND ® - Hemorrhage
    Clinical Study Number 1321.3
    Study Indication Hemorrhage
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0 g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial

    Study Document Trial synopsis 1321.3 english Lay summary 1321.3 english
  • PRAXBIND ® - Hemorrhage
    Clinical Study Number 1321.14
    Study Indication Hemorrhage
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase III/IV
    Study Title

    A compassionate use program of idarucizumab for reversal of the anticoagulant effects of dabigatran in Japanese patients who have uncontrolled bleeding or require emergency surgery or procedures

    Study Document Trial synopsis 1321.14 english
  • PRAXBIND ® - Hemorrhage
    Clinical Study Number 1321-0022
    Study Indication Hemorrhage
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase IV
    Study Title

    Medical Need of Non-vitamin K Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Emergency Surgery, Major Bleeding due to Trauma and Fracture, using Large Scale Claims Database

    Study Document Trial synopsis 1321-0022 english

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