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Clinical evaluation...
Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A
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Tarantino, MD (author)
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Collins, PW (author)
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Hay, CRM (author)
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Shapiro, AD (author)
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Gruppo, RA (author)
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- Berntorp, Erik (author)
- Lund University,Lunds universitet,Klinisk koagulationsmedicin, Malmö,Forskargrupper vid Lunds universitet,Clinical Coagulation, Malmö,Lund University Research Groups
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Bray, GL (author)
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Tonetta, SA (author)
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Schroth, PC (author)
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Retzios, AD (author)
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Rogy, SS (author)
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Sensel, MG (author)
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Ewenstein, BM (author)
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(creator_code:org_t)
- Wiley, 2004
- 2004
- English.
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In: Haemophilia. - : Wiley. - 1351-8216 .- 1365-2516. ; 10:5, s. 428-437
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Subject headings
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- The efficacy and safety of an advanced category recombinant antihaemophilic factor produced by a plasma- and albumin-free method (rAHF-PFM) was studied in 111 previously treated subjects with haemophilia A. The study comprised a randomized, double-blinded, crossover pharmacokinetic comparison of rAHF-PFM and RECOMBINATE rAHF (R-FVIII); prophylaxis (three to four times per week with 25-40 IU kg(-1) rAHF-PFM) for at least 75 exposure days; and treatment of episodic haemorrhagic events. Median age was 18 years, 96% of subjects had baseline factor VIII <1%, and 108 received study drug. Bioequivalence, based on area under the plasma concentration vs. time curve and adjusted in vivo recovery, was demonstrated for rAHF-PFM and R-FVIII. Mean (+/-SD) half-life for rAHF-PFM was 12.0 +/- 4.3 h. Among 510 bleeding events, 473 (93%) were managed with one or two infusions of rAHF-PFM and 439 (86%) had efficacy ratings of excellent or good. Subjects who were less adherent to the prophylactic regimen had a higher bleeding rate (9.9 episodes subject(-1) year(-1)) than subjects who were more adherent (4.4 episodes subject(-1) year(-1); P < 0.03). One subject developed a low titre, non-persistent inhibitor (2.0 BU) after 26 exposure days. These data demonstrate that rAHF-PFM is bioequivalent to R-FVIII, and suggest that rAHF-PFM is efficacious and safe, without increased immunogenicity, for the treatment of haemophilia A.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Keyword
- plasma-free method
- haemophilia A
- recombinant factor VIII
- recombinant antihaemophilic factor
- factor VIII
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Tarantino, MD
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Collins, PW
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Hay, CRM
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Shapiro, AD
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Gruppo, RA
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Berntorp, Erik
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show more...
-
Bray, GL
-
Tonetta, SA
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Schroth, PC
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Retzios, AD
-
Rogy, SS
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Sensel, MG
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Ewenstein, BM
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
- Articles in the publication
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Haemophilia
- By the university
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Lund University