Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Summary

The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.

Timeline

Start

2015-06

Primary completion

2015-07

Completion

2015-12

Outcome

Met primary endpoint

paper one-stage, AUClast: 1660 IU·h/dL [29.4] vs. 1310 IU·h/dL [29.0], p < 0.0001 PMID 28005225 ↗

Publications

• Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T. Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A. Clin Pharmacokinet. 2017 Sep;56(9):1045-1055. doi: 10.1007/s40262-016-0492-2.

Drugs

Indications