-
Je něco špatně v tomto záznamu ?
A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects
VS. Blanchette, L. Zunino, V. Grassmann, C. Barnes, MD. Carcao, J. Curtin, S. Jackson, L. Khoo, V. Komrska, D. Lillicrap, M. Morfini, G. Romanova, D. Stephens, E. Zapotocka, ML. Rand, J. Blatny
Jazyk angličtina Země Německo
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, pozorovací studie
Grantová podpora
Baxalta/Takeda
#IIRH15-27025
Baxalta U.S. Inc.
#IIRH15-27025
PubMed
33506480
DOI
10.1055/a-1376-0970
Knihovny.cz E-zdroje
- MeSH
- ambulantní péče MeSH
- biologické modely MeSH
- dítě MeSH
- dospělí MeSH
- faktor VIII aplikace a dávkování farmakokinetika MeSH
- hemofilie A krev diagnóza farmakoterapie MeSH
- hemokoagulace účinky léků MeSH
- klinické protokoly MeSH
- koagulancia aplikace a dávkování krev farmakokinetika MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- monitorování léčiv * MeSH
- prediktivní hodnota testů MeSH
- předškolní dítě MeSH
- prospektivní studie MeSH
- senioři MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Austrálie MeSH
- Česká republika MeSH
- Kanada MeSH
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] < 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.
Department of Biochemistry University of Toronto Toronto Ontario Canada
Department of Clinical Haematology University Hospital Brno Brno Czech Republic
Department of Clinical Research Services The Hospital for Sick Children Toronto Canada
Department of Haematology The Children's Hospital at Westmead Sydney Australia
Department of Laboratory Medicine and Pathobiology University of Toronto Toronto Ontario Canada
Department of Paediatric Haematology and Oncology University Hospital Motol Prague Czech Republic
Department of Paediatric Haematology University Hospital Brno Brno Czech Republic
Department of Paediatrics and Child Health University of Sydney Sydney Australia
Department of Paediatrics University of Toronto Toronto Ontario Canada
Department of Pathology and Molecular Medicine Queen's University Kingston Ontario Canada
Division of Haematology Oncology The Hospital for Sick Children Toronto Ontario Canada
Division of Haematology St Paul's Hospital Vancouver British Columbia Canada
Faculty of Medicine Masaryk University Brno Czech Republic
Haematology Department Royal Prince Alfred Hospital NSW Health Pathology Sydney Australia
Haematology Department The Royal Children's Hospital Melbourne Victoria Australia
Haematology Research Murdoch Children's Research Institute Victoria Australia
Italian Association of Haemophilia Centres Florence Italy
Translational Medicine Research Institute The Hospital for Sick Children Toronto Canada
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc22012180
- 003
- CZ-PrNML
- 005
- 20220506130210.0
- 007
- ta
- 008
- 220425s2021 gw f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1055/a-1376-0970 $2 doi
- 035 __
- $a (PubMed)33506480
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a gw
- 100 1_
- $a Blanchette, Victor S $u Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada $u Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada
- 245 12
- $a A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects / $c VS. Blanchette, L. Zunino, V. Grassmann, C. Barnes, MD. Carcao, J. Curtin, S. Jackson, L. Khoo, V. Komrska, D. Lillicrap, M. Morfini, G. Romanova, D. Stephens, E. Zapotocka, ML. Rand, J. Blatny
- 520 9_
- $a 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] < 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.
- 650 _2
- $a mladiství $7 D000293
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a ambulantní péče $7 D000553
- 650 _2
- $a hemokoagulace $x účinky léků $7 D001777
- 650 _2
- $a dítě $7 D002648
- 650 _2
- $a předškolní dítě $7 D002675
- 650 _2
- $a klinické protokoly $7 D002985
- 650 _2
- $a koagulancia $x aplikace a dávkování $x krev $x farmakokinetika $7 D003029
- 650 12
- $a monitorování léčiv $7 D016903
- 650 _2
- $a faktor VIII $x aplikace a dávkování $x farmakokinetika $7 D005169
- 650 _2
- $a hemofilie A $x krev $x diagnóza $x farmakoterapie $7 D006467
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a biologické modely $7 D008954
- 650 _2
- $a prediktivní hodnota testů $7 D011237
- 650 _2
- $a prospektivní studie $7 D011446
- 650 _2
- $a mladý dospělý $7 D055815
- 651 _2
- $a Austrálie $7 D001315
- 651 _2
- $a Kanada $7 D002170
- 651 _2
- $a Česká republika $7 D018153
- 655 _2
- $a srovnávací studie $7 D003160
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a pozorovací studie $7 D064888
- 700 1_
- $a Zunino, Laura $u Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
- 700 1_
- $a Grassmann, Viviane $u Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
- 700 1_
- $a Barnes, Chris $u Haematology Department, The Royal Children's Hospital Melbourne, Victoria, Australia $u Haematology Research, Murdoch Children's Research Institute, Victoria, Australia
- 700 1_
- $a Carcao, Manuel D $u Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada $u Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
- 700 1_
- $a Curtin, Julie $u Department of Haematology, The Children's Hospital at Westmead, Sydney, Australia $u Department of Paediatrics and Child Health, University of Sydney, Sydney, Australia
- 700 1_
- $a Jackson, Shannon $u Division of Haematology, St. Paul's Hospital, Vancouver, British Columbia, Canada
- 700 1_
- $a Khoo, Liane $u Haematology Department, Royal Prince Alfred Hospital, NSW Health Pathology, Sydney, Australia
- 700 1_
- $a Komrska, Vladimir $u Department of Paediatric Haematology and Oncology, University Hospital Motol, Prague, Czech Republic
- 700 1_
- $a Lillicrap, David $u Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada
- 700 1_
- $a Morfini, Massimo $u Italian Association of Haemophilia Centres, Florence, Italy
- 700 1_
- $a Romanova, Gabriela $u Department of Clinical Haematology, University Hospital Brno, Brno, Czech Republic $u Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Stephens, Derek $u Department of Clinical Research Services, The Hospital for Sick Children, Toronto, Canada
- 700 1_
- $a Zapotocka, Ester $u Department of Paediatric Haematology and Oncology, University Hospital Motol, Prague, Czech Republic
- 700 1_
- $a Rand, Margaret L $u Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada $u Translational Medicine, Research Institute, The Hospital for Sick Children, Toronto, Canada $u Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada $u Department of Biochemistry, University of Toronto, Toronto, Ontario, Canada $u Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada
- 700 1_
- $a Blatny, Jan $u Faculty of Medicine, Masaryk University, Brno, Czech Republic $u Department of Paediatric Haematology, University Hospital Brno, Brno, Czech Republic
- 773 0_
- $w MED00004517 $t Thrombosis and haemostasis $x 2567-689X $g Roč. 121, č. 10 (2021), s. 1326-1336
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/33506480 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20220425 $b ABA008
- 991 __
- $a 20220506130202 $b ABA008
- 999 __
- $a ok $b bmc $g 1789676 $s 1163381
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2021 $b 121 $c 10 $d 1326-1336 $e 20210127 $i 2567-689X $m Thrombosis and haemostasis $n Thromb Haemost $x MED00004517
- GRA __
- $a Baxalta/Takeda $p #IIRH15-27025
- GRA __
- $a Baxalta U.S. Inc. $p #IIRH15-27025
- LZP __
- $a Pubmed-20220425