Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: turoctocog alfa pegol
Intervention description: Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect
      of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. (Trial-related
             activities are any procedure that would not have been performed during normal
             management of the subject.)

          -  Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4
             (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP

          -  Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and
             wound status for at least 3 days

          -  The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a
             bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes
             and otherwise capable of following the trial procedures

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product including allergy to hamster
             protein or related products

          -  Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4
             (NN7088-3861) trial after administration of trial product, except interruption due to
             inclusion in this pathfinderTM 3 trial (NN7088-3860)

          -  The receipt of any investigational medicinal product (except N8-GP) within 30 days
             prior to enrolment into the trial. (For Brazil, only: Participation in a previous
             clinical trial within one year prior to screening for this trial (Visit 1), unless
             there is a direct benefit to the research subject, at the Investigator's discretion)

          -  FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening

          -  Previous arterial thrombotic events (e.g. myocardial infarction and intracranial
             thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by
             available medical records)

          -  Immune modulating or chemotherapeutic medication

          -  Any disease (liver, kidney, inflammatory and mental disorders included) or condition
             which, according to the Investigator's judgement, could imply a potential hazard to
             the patient, interfere with trial participation or trial outcome

          -  Unwillingness, language or other barriers precluding adequate understanding and/or
             cooperation