Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
Condition: Blood Coagulation Disorders; Hemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: Recombinant Factor VIII (BAY81-8973); Recombinant Factor VIII (Kogenate FS, BAY14-2222); Recombinant Factor VIII (BAY81-8973); Recombinant Factor VIII (BAY81-8973)
Intervention description: Single dose of BAY81-8973 crossed over to single dose of Kogenate FS; Single dose of Kogenate FS crossed over to Single dose of BAY81-8973; Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.; Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Male
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hemophilia A; Factor VIII; Prophylaxis

Summary:

      The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of
      prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period
      (split into two six month treatment periods). The study will compare 2 different methods
      (assays) for measuring the amount of study drug, the chromogenic substrate assay per European
      Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ).
      During one six month period patients will receive the study drug where the dose has been
      measured using the" (CS/EP) and during the other six months period the dose will be measured
      based on the Chromogenic Substrate Adjusted assay CS/ADJ)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, aged 12 to 65 years

          -  Severe hemophilia A defined as < 1% FVIII:C

          -  >/= 150 days of previous treatment with FVIII in lifetime

          -  Currently receiving on-demand or any type of prophylaxis treatment regimen with any
             FVIII product

          -  No history of or current FVIII inhibitors

        Exclusion Criteria:

          -  Presence of another bleeding disease that is different from hemophilia A (e.g., von
             Willebrand disease, hemophilia B)

          -  Low platelet count, abnormal kidney function, or liver disease

          -  Received treatment with immune suppressing drugs within the last 3 months prior or
             requires treatment during the study. (Some drugs for hepatitis C, Human
             immunodeficiency virus (HIV), and steroids are allowed)

          -  Receiving or has received other experimental drugs within 3 months prior to study
             entry

          -  Allergy to Factor VIII or hamsters or mouse protein