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
Phase of Trial: Phase III
Latest Information Update: 01 Dec 2017
At a glance
- Drugs Prothrombin complex concentrate (Primary)
- Indications Haemorrhage; Surgical blood loss
- Focus Registrational; Therapeutic Use
- Sponsors CSL Behring
- 01 Dec 2017 Results published in the International Journal of Hematology
- 01 Apr 2016 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
- 27 Jan 2016 Planned End Date changed from 1 Feb 2016 to 1 Mar 2016 as reported by ClinicalTrials.gov record.