Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Damoctocog alfa pegol (Jivi, BAY94-9027)
Intervention description: The recommended starting dose is every 5 days treatment (45 IU/kg)- An assessment of response to treatment will be performed at the next scheduled visit after 10-15 ED (8-10 weeks). Participants may be assigned to different dosing regimens (every 7 days or 2x/week) or continue with every 5 days regimen, according to individual bleeding tendency and needs at investigator's discretion.
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to give gather more information on how safe and well Jivi works in
      patients with severe hemophilia A. Jivi has been approved by various regulatory agencies,
      including the FDA, Health Canada, Japanese Health Authority and the European Medicinal
      Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending
      on their treatment frequency. Researcher will monitor during the course of the study whether
      patients are developing antibodies (a protein made by the body in response to the drug)
      affecting the effectiveness of Jivi. In addition information on bleedings and patient's
      wellbeing will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must ≥ 18 years of age inclusive, at the time of signing the informed
             consent.

          -  Participants with severe hemophilia A (FVIII: C<1%)

          -  PTPs (Previously treated patients) (≥150 ED (Exposure day)) on prophylaxis treatment
             before enrollment

          -  Participants who are immunocompetent. If human immunodeficiency virus (HIV) positive,
             cluster of differentiation 4 (CD4)+ lymphocyte count >200/mm*3

          -  Participants who are willing to complete an eDiary

          -  Male participants

          -  Capable of giving signed informed consent

        Exclusion Criteria:

          -  Any other inherited or acquired bleeding disorder in addition to Hemophilia A.

          -  Platelet count < 100,000/mm*3

          -  Creatinine > 2x upper limit of normal

          -  AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine
             aminotransferase)

          -  The participant has a planned major surgery.

          -  The participant is currently participating in another investigational drug study, or
             has participated in a clinical study involving an investigational drug within 30 days
             of signing informed consent or previous treatment in a clinical phase III study with
             BAY 94-9027 (now marketed as Jivi).

          -  Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer
             ≥ 0.6 Bethesda unit (BU).

          -  Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.