Efficacy and safety of low-dose prophylaxis of highly purified plasma-derived factor VIII concentrate produced by the National Blood Centre, Thai Red Cross Society
Corresponding Author
Ampaiwan Chuansumrit
Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Correspondence: Ampaiwan Chuansumrit, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchathewi District, Bangkok 10400, Thailand ([email protected]).Search for more papers by this authorDarintr Sosothikul
Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand
Search for more papers by this authorRungrote Natesirinilkul
Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Search for more papers by this authorYujinda Lektrakul
Division of Pediatrics, Sappasitthiprasong Hospital, Ubon Ratchathani, Thailand
Search for more papers by this authorUbonwon Charoonruangrit
The National Blood Centre, Thai Red Cross Society, Bangkok, Thailand
Search for more papers by this authorFactor VIII Study Group
Members of the Factor VIII Study Group are listed in the Appendix S1.Search for more papers by this authorCorresponding Author
Ampaiwan Chuansumrit
Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Correspondence: Ampaiwan Chuansumrit, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchathewi District, Bangkok 10400, Thailand ([email protected]).Search for more papers by this authorDarintr Sosothikul
Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand
Search for more papers by this authorRungrote Natesirinilkul
Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Search for more papers by this authorYujinda Lektrakul
Division of Pediatrics, Sappasitthiprasong Hospital, Ubon Ratchathani, Thailand
Search for more papers by this authorUbonwon Charoonruangrit
The National Blood Centre, Thai Red Cross Society, Bangkok, Thailand
Search for more papers by this authorFactor VIII Study Group
Members of the Factor VIII Study Group are listed in the Appendix S1.Search for more papers by this author
Supporting Information
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REFERENCES
- 1 Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO Technical Report, Series No. 924, 2004.
- 2Kim IS, Choi YW, Kang Y, Sung HM, Shin JS. Dry-heat treatment process for enhancing viral safety of an antihemophilic factor VIII concentrate prepared from human plasma. J Microbiol Biotechnol. 2008; 18(5): 997-1003.
- 3 European Pharmacopoeia, 8th edition, Strasbourg, France, European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, 2013.
- 4 Guideline on plasma derived medicinal products; EMA/CHMP/BWP/70627/2010, rev. 4, 21 July 2011.
- 5 Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products. EMA/CHMP/BPWP/1619/1999. rev. 2, 28 January 2016.
- 6Hardisty RM, Macpherson JC. A one-stage factor VIII (antihaemophilic globulin) assay and its use on venous and capillary plasma. Thromb Diath Haemorrh 1962; 7: 215-228.
- 7Duncan E, Collecutt M, Street A. Nijmegen-Bethesda assay to measure factor VIII inhibitors. Methods Mol Biol 2013; 992: 321-333.
- 8Lillicrap D, Poon MC, Walker I, Xie F, Schwartz BA, Association of Hemophilia Clinic Directors of Canada. Efficacy and safety of the factor VIII/von Willebrand factor concentrate, haemate-P/humate-P: ristocetin cofactor unit dosing in patients with von Willebrand disease. Thromb Haemost 2002; 87(2): 224-230.
- 9Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llinas A, Ludlam CA, Mahlangu JN, Mulder K, Poon MC, Street A, Treatment guidelines working group on behalf of the World Federation of Hemophilia. Guidelines for the management of hemophilia. Haemophilia 2013; 19(1): e1-e47.
- 10Chuansumrit A, Isarangkura P, Hathirat P. Prophylactic treatment for hemophilia A patients: a pilot study. Southeast Asian J Trop Med Public Health 1995; 26(2): 243-246.