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Measuring factor VIII activity in samples from patients treated with N8‐GP (Esperoct ® ; turoctocog alfa pegol) during the pathfinder clinical trials programme
Author(s) -
Møss Judi,
Clausen Wan Hui Ong,
Ezban Mirella
Publication year - 2021
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/hae.14173
Subject(s) - medicine , clinical trial , analyser , nuclear medicine , chromatography , chemistry
FVIII activity in samples taken at various time points from 21 patients treated with N8‐GP (Esperoct ® ; turoctocog alfa pegol) during the pathfinder clinical trial programme was assessed and compared using different assay methods. FVIII activity measurements in samples from patients treated with N8‐GP were similar using chromogenic assays, regardless of calibration method or kit/analyser combination. FVIII activity measurements using one‐stage aPTT‐based assays were slightly lower when calibrated using normal human plasma (NHP) compared with a product‐specific standard; this difference may be partially attributable to differences in the aPTT reagent/analyser combinations used to perform the measurements. Overall, these results confirm the accuracy of FVIII activity measurements using N8‐GP‐treated patient samples and routine clinical laboratory methods with NHP calibration.