drugset / Trial / NCT02548143
LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 75 ug/kg | Intravenous |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 200 ug/kg | Intravenous |