Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Intervention: turoctocog alfa
Intervention description: Patients will receive standard prophylaxis treatment and treatment of bleeding episodes, according to label. Trial product will be administered as intravenous injections (i.v.)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will test the well-known medicine turoctocog alfa for any side effects. The
      purpose is to test turoctocog alfa for any side effects in the Indian population. The
      participants will get turoctocog alfa. Turoctocog alfa is already a well-known medicine in
      India, and can be prescribed by the study doctor. The participants will get an injection
      every second day or 3 times per week. This is decided by the study doctor. The study doctor
      will decide the amount and how often the participants must take the medicine. The study will
      last for about 16 weeks. The participants will have 5 visits with the study doctor. If the
      participants agree to participate in this study, the participants will receive the first
      injection at the second visit, thereafter the participants will be trained to do the
      injection by themself.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine suitability for the trial - Male, age above or equal to
        12 years at the time of signing informed consent - Patients with the diagnosis of
        congenital moderate or severe Haemophilia A based on medical records. (FVIII below or equal
        to 5%) - Documented history of at least 150 EDs (exposure days) to FVIII containing
        products Exclusion Criteria: - Confirmed inhibitors to FVIII (above or equal to 0.6 BU) at
        screening as assessed by central laboratory - History of FVIII inhibitors - Known or
        suspected hypersensitivity to trial product(s) or related products - Previous participation
        in this trial. Participation is defined as signed informed consent - Participation in any
        clinical trial of an approved or non-approved investigational medicinal product within 1
        month before screening (visit 1) - Any disorder, except for conditions associated with
        haemophilia A, which in the investigator's opinion might jeopardise patient's safety or
        compliance with the protocol - Immunocompromised patients due to HIV infection (defined as
        viral load above or equal to 400.000 copies/mL and/or CD4+ lymphocyte count below or equal
        to 200/μL). HIV status and CD4+ lymphocyte count /viral load results may be obtained at
        screening or from available medical records; results must be not older than 6 months -
        Known congenital or acquired coagulation disorders other than haemophilia A - Mental
        incapacity, unwillingness to cooperate, or a language barrier precluding adequate
        understanding and cooperation