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)

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 is greater
than or equal to (>=) 1%, then a repeat endogenous FVIII activity level will be
performed using the using the one stage clotting assay from the central laboratory. If
the repeated result is < 1 IU/dL (<1%), then the participant will meet 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 Recombinant FVIII (rFVIII) 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 rFVIII 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, would make 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 recombinant FVIII

- History of a positive inhibitor test or clinical signs of decreased response to FVIII
administrations. Family history of inhibitors will not exclude 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, make
the participant unsuitable for enrollment