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Items: 1 to 20 of 283

1.

Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B.

Powell JS, Pasi KJ, Ragni MV, Ozelo MC, Valentino LA, Mahlangu JN, Josephson NC, Perry D, Manco-Johnson MJ, Apte S, Baker RI, Chan GC, Novitzky N, Wong RS, Krassova S, Allen G, Jiang H, Innes A, Li S, Cristiano LM, Goyal J, Sommer JM, Dumont JA, Nugent K, Vigliani G, Brennan A, Luk A, Pierce GF; B-LONG Investigators.

N Engl J Med. 2013 Dec 12;369(24):2313-23. doi: 10.1056/NEJMoa1305074. Epub 2013 Dec 4.

2.

Long-acting recombinant factor IX Fc fusion protein (rFIXFc) for perioperative management of subjects with haemophilia B in the phase 3 B-LONG study.

Powell JS, Apte S, Chambost H, Hermans C, Jackson S, Josephson NC, Mahlangu JN, Ozelo MC, Peerlinck K, Pasi J, Perry D, Ragni MV, Wang X, Jiang H, Li S, Cristiano LM, Innes A, Nugent K, Brennan A, Luk A, Allen G, Pierce GF, Robinson B.

Br J Haematol. 2015 Jan;168(1):124-34. doi: 10.1111/bjh.13112. Epub 2014 Sep 11.

PMID:
25208598
3.

Recombinant factor IX Fc fusion protein in children with haemophilia B (Kids B-LONG): results from a multicentre, non-randomised phase 3 study.

Fischer K, Kulkarni R, Nolan B, Mahlangu J, Rangarajan S, Gambino G, Diao L, Ramirez-Santiago A, Pierce GF, Allen G.

Lancet Haematol. 2017 Feb;4(2):e75-e82. doi: 10.1016/S2352-3026(16)30193-4.

PMID:
28159192
4.

Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates.

Powell J, Shapiro A, Ragni M, Negrier C, Windyga J, Ozelo M, Pasi J, Baker R, Potts J, Li S, Mei B, Pierce GF, Robinson B.

Br J Haematol. 2015 Jan;168(1):113-23. doi: 10.1111/bjh.13109. Epub 2014 Sep 11.

PMID:
25209873
5.

Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B.

Pasi KJ, Fischer K, Ragni M, Nolan B, Perry DJ, Kulkarni R, Ozelo M, Mahlangu J, Shapiro AD, Baker RI, Bennett CM, Barnes C, Oldenburg J, Matsushita T, Yuan H, Ramirez-Santiago A, Pierce GF, Allen G, Mei B.

Thromb Haemost. 2017 Feb 28;117(3):508-518. doi: 10.1160/TH16-05-0398. Epub 2016 Dec 22.

PMID:
28004057
6.

Eftrenonacog Alfa: A Review in Haemophilia B.

Hoy SM.

Drugs. 2017 Jul;77(11):1235-1246. doi: 10.1007/s40265-017-0778-1.

PMID:
28646426
7.

Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients.

Shapiro AD, Ragni MV, Valentino LA, Key NS, Josephson NC, Powell JS, Cheng G, Thompson AR, Goyal J, Tubridy KL, Peters RT, Dumont JA, Euwart D, Li L, Hallén B, Gozzi P, Bitonti AJ, Jiang H, Luk A, Pierce GF.

Blood. 2012 Jan 19;119(3):666-72. doi: 10.1182/blood-2011-07-367003. Epub 2011 Nov 22.

8.

Results of a phase I/II open-label, safety and efficacy trial of coagulation factor IX (recombinant), albumin fusion protein in haemophilia B patients.

Martinowitz U, Lissitchkov T, Lubetsky A, Jotov G, Barazani-Brutman T, Voigt C, Jacobs I, Wuerfel T, Santagostino E.

Haemophilia. 2015 Nov;21(6):784-90. doi: 10.1111/hae.12721. Epub 2015 May 20.

9.

Continuous prophylaxis with recombinant factor IX Fc fusion protein and conventional recombinant factor IX products: comparisons of efficacy and weekly factor consumption.

Iorio A, Krishnan S, Myrén KJ, Lethagen S, McCormick N, Yermakov S, Karner P.

J Med Econ. 2017 Apr;20(4):337-344. doi: 10.1080/13696998.2016.1265973. Epub 2016 Dec 21.

PMID:
27885871
10.

Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates.

Roth DA, Kessler CM, Pasi KJ, Rup B, Courter SG, Tubridy KL; Recombinant Factor IX Study Group.

Blood. 2001 Dec 15;98(13):3600-6.

11.
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13.

Recombinant Factor IX Fc Fusion Protein Maintains Full Procoagulant Properties and Exhibits Prolonged Efficacy in Hemophilia B Mice.

Toby GG, Liu T, Buyue Y, Zhang X, Bitonti AJ, Pierce GF, Sommer JM, Jiang H, Peters RT.

PLoS One. 2016 Feb 3;11(2):e0148255. doi: 10.1371/journal.pone.0148255. eCollection 2016.

14.

Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A.

Young G, Mahlangu J, Kulkarni R, Nolan B, Liesner R, Pasi J, Barnes C, Neelakantan S, Gambino G, Cristiano LM, Pierce GF, Allen G.

J Thromb Haemost. 2015 Jun;13(6):967-77. doi: 10.1111/jth.12911. Epub 2015 Apr 23.

15.

Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial.

Santagostino E, Martinowitz U, Lissitchkov T, Pan-Petesch B, Hanabusa H, Oldenburg J, Boggio L, Negrier C, Pabinger I, von Depka Prondzinski M, Altisent C, Castaman G, Yamamoto K, Álvarez-Roman MT, Voigt C, Blackman N, Jacobs I; PROLONG-9FP Investigators Study Group.

Blood. 2016 Apr 7;127(14):1761-9. doi: 10.1182/blood-2015-09-669234. Epub 2016 Jan 11.

16.

Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial.

Carcao M, Zak M, Abdul Karim F, Hanabusa H, Kearney S, Lu MY, Persson P, Rangarajan S, Santagostino E.

J Thromb Haemost. 2016 Aug;14(8):1521-9. doi: 10.1111/jth.13360. Epub 2016 Jun 22.

PMID:
27174727
17.

Pharmacokinetics, efficacy and safety of BAX326, a novel recombinant factor IX: a prospective, controlled, multicentre phase I/III study in previously treated patients with severe (FIX level <1%) or moderately severe (FIX level ≤2%) haemophilia B.

Windyga J, Lissitchkov T, Stasyshyn O, Mamonov V, Rusen L, Lamas JL, Oh MS, Chapman M, Fritsch S, Pavlova BG, Wong WY, Abbuehl BE.

Haemophilia. 2014 Jan;20(1):15-24. doi: 10.1111/hae.12228. Epub 2013 Jul 9.

PMID:
23834666
18.

Prolonged activity of factor IX as a monomeric Fc fusion protein.

Peters RT, Low SC, Kamphaus GD, Dumont JA, Amari JV, Lu Q, Zarbis-Papastoitsis G, Reidy TJ, Merricks EP, Nichols TC, Bitonti AJ.

Blood. 2010 Mar 11;115(10):2057-64. doi: 10.1182/blood-2009-08-239665. Epub 2010 Jan 7.

19.

Efficacy and safety of long-acting recombinant fusion protein linking factor IX with albumin in haemophilia B patients undergoing surgery.

Négrier C, Abdul Karim F, Lepatan LM, Lienhart A, López-Fernández MF, Mahlangu J, Pabinger I, Li Y, Wolko D, Voigt C, Jacobs I, Santagostino E.

Haemophilia. 2016 Jul;22(4):e259-66. doi: 10.1111/hae.12972. Epub 2016 Jun 22.

PMID:
27333467
20.

Population pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) in patients with haemophilia B.

Diao L, Li S, Ludden T, Gobburu J, Nestorov I, Jiang H.

Clin Pharmacokinet. 2014 May;53(5):467-77. doi: 10.1007/s40262-013-0129-7.

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