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Blanchette, Victor S.; Zunino, Laura; Grassmann, Viviane; Barnes, Chris; Carcao, Manuel D.; Curtin, Julie; Jackson, Shannon; Khoo, Liane; Komrska, Vladimir; Lillicrap, David; Morfini, Massimo; Romanova, Gabriela; Stephens, Derek; Zapotocka, Ester; Rand, Margaret L.; Blatny, Jan

A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects

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  • Medientyp: E-Artikel
  • Titel: A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects
  • Beteiligte: Blanchette, Victor S.; Zunino, Laura; Grassmann, Viviane; Barnes, Chris; Carcao, Manuel D.; Curtin, Julie; Jackson, Shannon; Khoo, Liane; Komrska, Vladimir; Lillicrap, David; Morfini, Massimo; Romanova, Gabriela; Stephens, Derek; Zapotocka, Ester; Rand, Margaret L.; Blatny, Jan
  • Erschienen: Georg Thieme Verlag KG, 2021
  • Erschienen in: Thrombosis and Haemostasis
  • Sprache: Englisch
  • DOI: 10.1055/a-1376-0970
  • ISSN: 0340-6245; 2567-689X
  • Entstehung:
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  • Beschreibung: <jats:title>Abstract</jats:title><jats:p>Standard pharmacokinetic (PK) assessments are demanding for persons with hemophilia A, requiring a 72-hour washout and 5 to 11 timed blood samples. A no-washout, single-clinic visit, sparse sampling population PK (PPK) protocol is an attractive alternative. Here, we compared PK parameters obtained with a traditional washout, 6-sampling time point PPK protocol with a no-washout, single-clinic visit, reverse 2-sampling time point PPK protocol in persons with severe hemophilia A (SHA) receiving ADVATE. A total of 39 inhibitor-negative males with SHA (factor VIII activity [FVIII:C] &lt; 2%) were enrolled in a prospective sequential design PK study. Participants completed a washout, 6-sampling time point PPK protocol as well as a no-washout, reverse 2-sampling time point protocol, with samples taken during a single 3-hour clinic visit 24 hours post home infusion of FVIII and then 3 hours post infusion in clinic. FVIII:C levels were analyzed by one-stage and chromogenic assays; blood group and von Willebrand factor antigen (VWF:Ag) were determined; and PK parameters were analyzed using the ADVATE myPKFiT dosing tool. There was moderate to almost perfect agreement for the PK parameters obtained with the 2- and the 6- point PPK protocols using a one-stage FVIII:C assay and a substantial to almost perfect agreement using a chromogenic FVIII:C assay. Significant associations between specific PK parameters and blood group and VWF:Ag were observed. The no-washout, single-clinic visit, reverse 2-sampling time point PPK protocol can be used in the routine clinical setting since it demonstrates sufficient accuracy compared with the more demanding and less practical washout, 6-sampling time point PPK protocol in persons with SHA receiving ADVATE.</jats:p>