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Advancing personalized care in hemophilia A: ten years' experience with an advanced category antihemophilic factor prepared using a plasma/albumin-free method.

Berntorp E, Spotts G, Patrone L, Ewenstein BM.

Biologics. 2014 Apr 5;8:115-27. doi: 10.2147/BTT.S53456. eCollection 2014. Review.


Matching-adjusted indirect comparisons of efficacy of BAY 81-8973 vs two recombinant factor VIII for the prophylactic treatment of severe hemophilia A.

Pocoski J, Li N, Ayyagari R, Church N, Maas Enriquez M, Xiang Q, Kelkar S, Du EX, Wu EQ, Xie J.

J Blood Med. 2016 Jul 4;7:129-37. doi: 10.2147/JBM.S104074. eCollection 2016.


Plasma and albumin-free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients.

Blanchette VS, Shapiro AD, Liesner RJ, Hernández Navarro F, Warrier I, Schroth PC, Spotts G, Ewenstein BM; rAHF-PFM Clinical Study Group.

J Thromb Haemost. 2008 Aug;6(8):1319-26. doi: 10.1111/j.1538-7836.2008.03032.x. Epub 2008 May 22.


Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A.

Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T.

Clin Pharmacokinet. 2017 Sep;56(9):1045-1055. doi: 10.1007/s40262-016-0492-2.


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.

Tarantino MD, Collins PW, Hay CR, Shapiro AD, Gruppo RA, Berntorp E, Bray GL, Tonetta SA, Schroth PC, Retzios AD, Rogy SS, Sensel MG, Ewenstein BM; RAHF-PFM Clinical Study Group.

Haemophilia. 2004 Sep;10(5):428-37.


Prophylaxis and quality of life in patients with hemophilia A during routine treatment with ADVATE [antihemophilic factor (recombinant), plasma/albumin-free method] in Germany: a subgroup analysis of the ADVATE PASS post-approval, non-interventional study.

Pollmann H, Klamroth R, Vidovic N, Kriukov AY, Epstein J, Abraham I, Spotts G, Oldenburg J.

Ann Hematol. 2013 May;92(5):689-98. doi: 10.1007/s00277-013-1678-4. Epub 2013 Jan 17. Erratum in: Ann Hematol. 2013 Jul;92(7):1005.


A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management.

Valentino LA, Mamonov V, Hellmann A, Quon DV, Chybicka A, Schroth P, Patrone L, Wong WY; Prophylaxis Study Group.

J Thromb Haemost. 2012 Mar;10(3):359-67. doi: 10.1111/j.1538-7836.2011.04611.x.


Integrated analysis of safety data from 12 clinical interventional studies of plasma- and albumin-free recombinant factor VIII (rAHF-PFM) in haemophilia A.

Shapiro AD, Schoenig-Diesing C, Silvati-Fidell L, Wong WY, Romanov V.

Haemophilia. 2015 Nov;21(6):791-8. doi: 10.1111/hae.12724. Epub 2015 May 25.


Stability of ADVATE, Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method, during simulated continuous infusion.

Fernandez M, Yu T, Bjornson E, Luu H, Spotts G.

Blood Coagul Fibrinolysis. 2006 Apr;17(3):165-71.


Recombinant factor VIII Fc fusion protein: extended-interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels.

Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, Pasi KJ, Hanabusa H, Pabinger I, Mahlangu J, Fogarty P, Lillicrap D, Kulke S, Potts J, Neelakantan S, Nestorov I, Li S, Dumont JA, Jiang H, Brennan A, Pierce GF.

J Thromb Haemost. 2014 Nov;12(11):1788-800. doi: 10.1111/jth.12723. Epub 2014 Oct 10.


Efficacy assessment of a new clotting factor concentrate in haemophilia A patients, including prophylactic treatment.

Den Uijl I, Mauser-Bunschoten EP, Roosendaal G, Schutgens R, Fischer K.

Haemophilia. 2009 Nov;15(6):1215-8. doi: 10.1111/j.1365-2516.2009.02079.x. Epub 2009 Aug 4.


Recombinant full-length factor VIII (FVIII) and extended half-life FVIII products in prophylaxis--new insight provided by pharmacokinetic modelling.

Gringeri A, Wolfsegger M, Steinitz KN, Reininger AJ.

Haemophilia. 2015 May;21(3):300-6. doi: 10.1111/hae.12605. Epub 2015 Jan 21.


Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A.

Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM.

Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392 .


PK-guided personalized prophylaxis with Nuwiq® (human-cl rhFVIII) in adults with severe haemophilia A.

Lissitchkov T, Rusen L, Georgiev P, Windyga J, Klamroth R, Gercheva L, Nemes L, Tiede A, Bichler J, Knaub S, Belyanskaya L, Walter O, Pasi KJ.

Haemophilia. 2017 Sep;23(5):697-704. doi: 10.1111/hae.13251. Epub 2017 Apr 27.


Factor VIII requirement to maintain a target plasma level in the prophylactic treatment of severe hemophilia A: influences of variance in pharmacokinetics and treatment regimens.

Collins PW, Björkman S, Fischer K, Blanchette V, Oh M, Schroth P, Fritsch S, Casey K, Spotts G, Ewenstein BM.

J Thromb Haemost. 2010 Feb;8(2):269-75. doi: 10.1111/j.1538-7836.2009.03703.x. Epub 2009 Nov 23.


Correlation between endogenous VWF:Ag and PK parameters and bleeding frequency in severe haemophilia A subjects during three-times-weekly prophylaxis with rFVIII-FS.

Lalezari S, Martinowitz U, Windyga J, Enriquez MM, Delesen H, Schwartz L, Scharrer I.

Haemophilia. 2014 Jan;20(1):e15-22. doi: 10.1111/hae.12294. Epub 2013 Nov 20. Erratum in: Haemophilia. 2014 Mar;20(2):e193.


Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: efficacy and safety of Advate in previously treated patients.

Négrier C, Shapiro A, Berntorp E, Pabinger I, Tarantino M, Retzios A, Schroth P, Ewenstein B.

Thromb Haemost. 2008 Aug;100(2):217-23.


Patient data meta-analysis of Post-Authorization Safety Surveillance (PASS) studies of haemophilia A patients treated with rAHF-PFM.

Iorio A, Marcucci M, Cheng J, Oldenburg J, Schoenig-Diesing C, Matovinovic E, Romanov V, Thabane L.

Haemophilia. 2014 Nov;20(6):777-83. doi: 10.1111/hae.12480. Epub 2014 Jul 17.

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