Last updated on January 2017

A Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) LR769 for the Prevention of Excessive Bleeding in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX Undergoing Elective Surgery or Other Invasive Procedure


Brief description of study

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.

Detailed Study Description

This study is an international, multicenter, single-arm, Phase 3 study. Patients aged 6 months to 75 years, inclusive, who have congenital hemophilia A or B with inhibitors to Factor VIII or Factor IX and who are scheduled for an elective surgical or other invasive procedure will be enrolled. Both major and minor surgical or other invasive procedures are allowed in the study. Initial Treatment: Regardless of procedure, patients who meet all eligibility criteria will receive an initial intravenous (IV) bolus dose of 75 - 200 µg/kg of LR769 administered within ≤2 minutes before the surgical incision or start of the invasive procedure. The initial dose will be selected by the investigator in conjunction with the surgeon/practitioner based on the complexity of the procedure, the number of tissue planes to be traversed, the patient's previous responses to bypassing agents, and other factors deemed relevant by the investigator. Administration will be repeated no more frequently than every 2 hours (±5 minutes) during and after surgery or invasive procedure. Treatment for Major Surgical Procedures: The initial dose of LR769 will be followed by repeated administration of 75 µg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours after completion of the procedure. The minimum duration of LR769 treatment for major procedures will be 5 days and dosing frequency will be followed according to the guidelines specified in the protocol. Treatment for Minor Surgical or Other Invasive Procedures: The initial dose of LR769 will be followed by repeated administration of 75 µg/kg of LR769 every 2 hours (±5 minutes) for the first 48 hours. The minimum duration of LR769 infusion for minor procedures will be 2 days, except for certain procedures that may not require this duration of treatment to achieve hemostasis as noted below.

Clinical Study Identifier: NCT02548143

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Ievgenii Averianov, MD

City Scientific-Practical center for diagnosics
Kiev, Ukraine
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