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Clinical trial

An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure

NCT02281201 is registered in ClinicalTrials.gov with CSL Behring as lead sponsor.

NCT NCT02281201
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure
Lead sponsor
CSL Behring
Phase
Phase 3
Overall status
Completed
Start date
October 31, 2014
Completion date
March 31, 2016
Enrollment
11 (actual)
Sites
11

Conditions

As the registry lists them; a condition with its own page is linked.

acute major bleeding, reversal of coagulopathy