A practical, one-clinic visit protocol for pharmacokinetic profile generation with the ADVATE(R) myPKFiT(R) dosing tool in severe hemophilia A subjects

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F21%3A10421710" target="_blank" >RIV/00064203:_____/21:10421710 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/21:10421710

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=_kqql9cTpW" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=_kqql9cTpW</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1055/a-1376-0970" target="_blank" >10.1055/a-1376-0970</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A practical, one-clinic visit protocol for pharmacokinetic profile generation with the ADVATE(R) myPKFiT(R) dosing tool in severe hemophilia A subjects

Popis výsledku v původním jazyce

Standard pharmacokinetic (PK) assessments are demanding for persons with hemophilia A, requiring a 72hr washout and 5-11 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(R). 39 inhibitor-negative males with SHA (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 3hr clinic visit 24hr-post home infusion of FVIII and then 3hr-post infusion in clinic. FVIII:C levels were analyzed by one-stage and chromogenic assays; blood group and VWF:Ag were determined; and PK parameters were analyzed using the ADVATE(R) myPKFiT(R) 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 to the more demanding and less practical washout, 6-sampling time point PPK protocol in persons with SHA receiving ADVATE(R).

Název v anglickém jazyce

A practical, one-clinic visit protocol for pharmacokinetic profile generation with the ADVATE(R) myPKFiT(R) dosing tool in severe hemophilia A subjects

Popis výsledku anglicky

Standard pharmacokinetic (PK) assessments are demanding for persons with hemophilia A, requiring a 72hr washout and 5-11 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(R). 39 inhibitor-negative males with SHA (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 3hr clinic visit 24hr-post home infusion of FVIII and then 3hr-post infusion in clinic. FVIII:C levels were analyzed by one-stage and chromogenic assays; blood group and VWF:Ag were determined; and PK parameters were analyzed using the ADVATE(R) myPKFiT(R) 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 to the more demanding and less practical washout, 6-sampling time point PPK protocol in persons with SHA receiving ADVATE(R).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Thrombosis and Haemostasis

ISSN

0340-6245

e-ISSN

—

Svazek periodika

121

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

DE - Spolková republika Německo

Počet stran výsledku

11

Strana od-do

1326-1336

Kód UT WoS článku

000640018700001

EID výsledku v databázi Scopus

2-s2.0-85104487837