BAY94-9027 PK Study Comparing to Another Long Acting Product

Summary

The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.

Timeline

Start

2017-11-30

Primary completion

2018-01-25

Completion

2018-09-28

Outcome

Met primary endpoint

paper AUClast was significantly higher for BAY 94-9027 versus rFVIIIFc (2940 [37.8, 2440-3550] IU h/dL versus 2360 [31.8, 2010-2770] IU h/dL, p = 0.0001). PMID 31236667 ↗

Publications

• Shah A, Solms A, Wiegmann S, Ahsman M, Berntorp E, Tiede A, Iorio A, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019 Sep;98(9):2035-2044. doi: 10.1007/s00277-019-03747-2. Epub 2019 Jun 24.

Drugs

Indications