A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A ' B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150

Trial Profile

A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A ' B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150

Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 01 Nov 2016

At a glance

  • Drugs BAY 866150 (Primary) ; Eptacog alfa
  • Indications Haemophilia A; Haemophilia B
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms TRUST
  • Sponsors Bayer
  • Most Recent Events

    • 04 Oct 2014 New source identified and integrated (European Clinical Trials database record:EudraCT2011-000323-33).
    • 27 Mar 2014 New trial record
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