drugset / Trial / NCT02548143

LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures

NCT02548143

Phase 3 Completed 12 enrolled LFB LFB USA, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgical or other invasive procedures. Administration of LR769 will be performed just prior to surgery/procedure and will be repeated during and after the surgery/procedure to achieve and maintain adequate hemostasis as determined by the investigator's judgment.

Timeline

Start
2016-08-25
Primary completion
2017-08-06
Completion
2017-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject eptacog alfa (activated) Protein / enzyme biologic 75 ug/kg Intravenous
Subject eptacog alfa (activated) Protein / enzyme biologic 200 ug/kg Intravenous

Indications