Pharmacokinetics of rFVIIIFc at Two Vial Strengths

Completed · Phase 1

Conditions studied: Severe Hemophilia A

In brief

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.

Key facts

Study ID

NCT02083965

Run by

Bioverativ Therapeutics Inc.

People needed

19

Starts

2014-03-01

Expected to finish

2015-05-01

Last updated by the study team

2020-12-19

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

Where it is running

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

Full record on ClinicalTrials.gov

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