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Pharmacokinetics of rFVIIIFc at Two Vial Strengths

NCT02083965

CompletedPhase 1

Sponsor: Bioverativ Therapeutics Inc.

Conditions: Severe Hemophilia A

Interventions: rFVIIIFc

Countries: United States, Australia, United Kingdom

The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.

Eligibility overview

Sex: MALE

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Have severe hemophilia A
* Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
* No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not exclude subjects.
* No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at Screening.
* Platelet count ≥100,000 platelets/μL at screening
* CD4 lymphocytes \>200 mm3 if known as HIV antibody positive at screening.
* Viral load of \<400 copies/mL if known HIV antibody positive at screening.

Key Exclusion Criteria:

* Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion.
* Previous treatment with rFVIIIFc as study drug or commercial product.
* Other coagulation disorder(s) in addition to hemophilia A.
* History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration.
* Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted).
* Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids.

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

Locations (8)

Los Angeles, California, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Herston, Australia
Perth, Australia
Basingstoke, United Kingdom
Cambridge, United Kingdom
London, United Kingdom