A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)

Launched by BIOVERATIV, A SANOFI COMPANY · Jun 29, 2017

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Ability of the participant, or his legally authorized representative (e.g., parent or legal guardian) if applicable in accordance with local regulations, to understand the purpose and risks of the study and provide signed and dated informed consent/assent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
• • Severe hemophilia A, defined as less than (\<) 1 international units per deciliter (IU/dL) (\<1 percent \[%\]) endogenous FVIII at screening as determined by the one-stage clotting assay from the central laboratory. If the initial screening result was greater than or equal to (\>=) 1%, then a repeat endogenous FVIII activity level was performed using the one stage clotting assay from the central laboratory. If the repeated result was \< 1 IU/dL (\<1%), then the participant met this inclusion requirement.
• • Previous treatment for hemophilia A, defined as at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
• • Platelet count \>=100,000 cells/ microliter (mcL) at screening (test performed by the central laboratory and reviewed prior to the Day 1 Advate dose).
• • A participant known to be human immunodeficiency virus (HIV) antibody positive, either previously documented or identified from screening assessments, must have the following results prior to Day 1 Advate dose: cluster of differentiation 4 (CD4) lymphocyte count greater than (\>) 200 cells/millimeter (mm)\^3; viral load of \<400 copies/mL.
• Exclusion Criteria:
• Medical History:
• • Any concurrent clinically significant major disease that, in the opinion of the Investigator, made the participant unsuitable for enrollment.
• • Serious active bacterial or viral infection (other than chronic hepatitis or HIV) present within 30 days of screening.
• • Other known coagulation disorder(s) in addition to hemophilia A.
• • History of hypersensitivity or anaphylaxis associated with any FVIII product.
• • Known or suspected allergy to mice, hamsters, or any ingredient in Advate.
• • History of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors not excluded the participant.
• Medications and Procedures:
• • - Current enrollment or participation within 30 days prior to screening in any other investigational study.
• Other:
• • Inability to comply with study requirements as assessed by the Investigator.
• • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, made the participant unsuitable for enrollment.