Sixteen Years of Treatment with Pasteurized Human Clotting Factor Concentrates in Children and Adolescents: A Pharmacosurveillance Investigation Comprising 727 Patient Years

Muntean, W.; Zenz, Werner; Falger, Jutta; Male, Christoph; Streif, Werner; Wank, Johann; Schwarz, Rudolf; Schimrigk, К.; Kurnik, Peter B.; Zwiauer, Karl

doi:10.1055/s-2002-30198

Cited by 5 publications

(5 citation statements)

References 32 publications

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“…While no patients had seroconverted to HIV and only one patient had seroconverted to HCV, all other seroconversions registered were due to vaccination against hepatitis A and B. Similarly, lack of product‐related infectious disease was found in 81 Austrian patients followed in a mixture of a retrospective and a 2 years prospective trial covering 772 patient‐years [2,3].…”

Section: Section 2: European Principles Of Haemophilia Care – Detail mentioning

confidence: 99%

European principles of haemophilia care

et al. 2008

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Summary. As the management of haemophilia is complex, it is essential that those with the disorder should have ready access to a range of services provided by a multidisciplinary team of specialists. This document sets out the principles of comprehensive haemophilia care in Europe. Within each country there should be a national organization which oversees the provision of specialist Comprehensive Care Centres that provide the entire spectrum of clinical and laboratory services. Depending upon the size and geographical distribution of the population, a network of smaller haemophilia centres may also be necessary. There should be arrangements for the supply of safe clotting factor concentrates which can also be used in home treatment and prophylaxis programmes. A national register of patients is recommended along with collection of treatment statistics. As comprehensive haemophilia care is multidisciplinary by nature, the need for education and research programmes for all staff members is emphasized: Members of the Interdisciplinary Working Group not represented in the list of authors are mentioned in Section 4 of this document.

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Section: Section 2: European Principles Of Haemophilia Care – Detail mentioning

confidence: 99%

European principles of haemophilia care

et al. 2008

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“…The average content of high molecular weight VWF multimers (bands ≥ 11) in this concentrate is 84.1% of the corresponding bands in normal human plasma, the highest percentage initially among six and subsequently 12 concentrates tested in comparative studies [8,12,13]. In addition to its clinical efficacy, Haemate ® P has also demonstrated an excellent safety record over the past 25 years of clinical use [14–19].…”

Section: Introductionmentioning

confidence: 99%

von Willebrand factor/factor VIII concentrate (Haemate® P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery

Lethagen

Kyrle

Castaman

et al. 2007

Journal of Thrombosis and Haemostasis

111

165

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factor/factor VIII concentrate (Haemate R P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery. J Thromb Haemost 2007; 5: 1420-30.Summary. Background: While plasma-derived concentrates containing large amounts of von Willebrand factor (VWF) are effective in treating von Willebrand disease (VWD), optimal dosing remains to be fully characterized. Objectives: To determine the feasibility of dosing Haemate P Ò VWF/factor VIII (FVIII) concentrate based on pharmacokinetics (PK) in the management of surgical subjects with VWD. Methods: VWD subjects scheduled for elective surgery were enrolled in a prospective multicenter open-label cohort study. A pre-operative loading dose of VWF/FVIII concentrate based upon prior individual subject PK analysis was administered followed by postoperative therapeutic/maintenance infusions. Results: Twenty-eight subjects with types 1, 2A or 3 VWD and one with type 2 M were enrolled. Median in vivo recovery of VWF ristocetin cofactor (VWF:RCo) was 1.9 IU dL )1 (IU kgwith an interquartile range (IQR) of 1.6-2.5 IU dL. Median response, half-life and clearance were 74.0% (IQR, 55.5-100%), 15.6 h (IQR, 9.0-28.4 h) and 3.26 mL kg ) was administered. Postoperative mean trough VWF:RCo levels of 62-73 IU dL )1 were sufficient to prevent bleeding. Investigators rated hemostasis excellent or good in 96.3% of subjects on the day of surgery and 100% on the next day and on day 14. A subject with multiple risk factors developed pulmonary embolism, which resolved without sequelae. Conclusions: Haemate P Ò provided effective and safe hemostasis in VWD subjects undergoing elective surgery. Selection of Haemate Ò P loading dose on the basis of VWF PK proved feasible.

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“…Other cohorts of patients treated with Haemate P also did not develop any serological or clinical evidence of HBV [21,22]. Long‐term follow‐up of German patients solely treated with Haemate P also revealed no serological or clinical evidence of product‐related HCV infection [18,21–25]. In a multicentre clinical trial utilizing a highly sensitive second‐generation anti‐HCV test, 110/111 (99%) paediatric patients treated with pasteurized Haemate P or Beriate HS were negative, and the authors concluded that these concentrates carry a very low risk of HCV [26].…”

Section: Viral Inactivationmentioning

confidence: 99%

“…A seminal 1987 report in the New England Journal of Medicine also showed that none of 26 patients solely treated with Haemate P and followed over a period of 12 months developed HBV or any serological signs of other viral infections, such as hepatitis A virus (HAV), cytomegalovirus, Epstein–Barr virus and HIV [20]. Other cohorts of patients treated with Haemate P also did not develop any serological or clinical evidence of HBV [21,22]. Long‐term follow‐up of German patients solely treated with Haemate P also revealed no serological or clinical evidence of product‐related HCV infection [18,21–25].…”

Section: Viral Inactivationmentioning

confidence: 99%

“…While pasteurization is expected to be most effective against lipid‐enveloped viruses, it has also been shown to inactivate many smaller non‐enveloped viruses, including poliovirus and, most importantly, HAV [17]. Reports have demonstrated an excellent safety record of Haemate P with respect to HAV [21,31,32]. Human parvovirus can also be reduced by >4.3 log with the Haemate P pasteurization process [33].…”

Section: Viral Inactivationmentioning

confidence: 99%

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Haemate^®P von Willebrand factor/factor VIII concentrate: 25 years of clinical experience

Schramm¹

2008

Haemophilia

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Although von Willebrand disease (VWD) has a very long history, our understanding and treatment of the bleeding disorder has only evolved during the past 50 years or so. It was not until the 1920s that VWD was first recognized as a disease separate from that of classical haemophilia. It then took another 30 years before the first effective treatment was developed. Since then, the medical management of VWD has evolved considerably, but not without its ups and downs. One of the key milestones in the evolution of the treatment of VWD was the development of Haemate P/Humate-P (CSL Behring) - the first virus-inactivated factor VIII plasma product. For 25 years, this concentrate has demonstrated excellent clinical efficacy and safety for patients with VWD and for those with haemophilia. This article provides an historical overview of the early landmark efforts to ensure a safe plasma-derived replacement product and outlines the clinical evolution in the use of Haemate P.

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Sixteen Years of Treatment with Pasteurized Human Clotting Factor Concentrates in Children and Adolescents: A Pharmacosurveillance Investigation Comprising 727 Patient Years

Cited by 5 publications

References 32 publications

European principles of haemophilia care

European principles of haemophilia care

von Willebrand factor/factor VIII concentrate (Haemate® P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery

Haemate^®P von Willebrand factor/factor VIII concentrate: 25 years of clinical experience

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Sixteen Years of Treatment with Pasteurized Human Clotting Factor Concentrates in Children and Adolescents: A Pharmacosurveillance Investigation Comprising 727 Patient Years

Cited by 5 publications

References 32 publications

European principles of haemophilia care

European principles of haemophilia care

von Willebrand factor/factor VIII concentrate (Haemate® P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery

Haemate®P von Willebrand factor/factor VIII concentrate: 25 years of clinical experience

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Haemate^®P von Willebrand factor/factor VIII concentrate: 25 years of clinical experience