LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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 LR769 within ≤2 minutes before the surgical
      incision or start of the invasive procedure. For a minor elective surgery or other minor
      invasive procedure, a dose of 75 μg/kg will be used as the initial dose; for a major elective
      surgery or other major invasive procedure, a dose of 200 μg/kg of LR769 will be used as the
      initial dose. For both minor and major procedures, administration will be repeated no more
      frequently than every 2 hours (±5 minutes) at a dose of 75 μg/kg 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 in the protocol. Dosing frequency will be according to the guidelines
      specified in protocol for minor surgical or other invasive procedures.
    

Intervention name(s): Coagulation Factor VIIa (Recombinant)
Intervention type(s): Biological
Intervention description(s): LR769
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment