Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale

Completed · Phase 3

Conditions studied: Severe Hemophilia A

In brief

The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously treated participants with severe hemophilia A. The secondary objectives are: to characterize the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial and 6000 IU/vial strengths; and to evaluate the safety of rFVIIIFc manufactured at the 15K scale.

Key facts

Study ID: NCT02502149
Run by: Bioverativ Therapeutics Inc.
People needed: 24
Starts: 2015-08-01
Expected to finish: 2017-06-01
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 — Chicago, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Louisville, Kentucky, United States
Research Site — East Lansing, Michigan, United States
Research Site — St Louis, Missouri, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Seattle, Washington, United States
Research Site — Camperdown, New South Wales, Australia
Research Site — Melbourne, Victoria, Australia
Research Site — Murdoch, Western Australia, Australia
Research Site — Grafton, Auckland, New Zealand
Research Site — Newtown, Wellington Region, New Zealand
Research Site — Christchurch, New Zealand
Research Site — Hamilton, New Zealand

Full record on ClinicalTrials.gov

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