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Items: 1 to 20 of 105

1.

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.

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.

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.

4.

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
5.

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
6.

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
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.

Evaluation of the toxicology, pharmacokinetics, and local tolerance of recombinant factor IX Fc fusion protein in animals.

Dumont JA, Loveday KS, Light DR, Pierce GF, Jiang H.

Thromb Res. 2015 Aug;136(2):371-8. doi: 10.1016/j.thromres.2015.01.020. Epub 2015 Jan 23.

9.

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.

10.

Comparative field study: impact of laboratory assay variability on the assessment of recombinant factor IX Fc fusion protein (rFIXFc) activity.

Sommer JM, Buyue Y, Bardan S, Peters RT, Jiang H, Kamphaus GD, Gray E, Pierce GF.

Thromb Haemost. 2014 Nov;112(5):932-40. doi: 10.1160/TH13-11-0971. Epub 2014 Aug 21.

11.

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
12.

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.

13.

Population pharmacokinetic modelling of factor IX activity after administration of recombinant factor IX in patients with haemophilia B.

Suzuki A, Tomono Y, Korth-Bradley JM.

Haemophilia. 2016 Sep;22(5):e359-66. doi: 10.1111/hae.12969. Epub 2016 Jun 28.

PMID:
27353956
14.

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein.

McCue J, Osborne D, Dumont J, Peters R, Mei B, Pierce GF, Kobayashi K, Euwart D.

Haemophilia. 2014 Jul;20(4):e327-35. doi: 10.1111/hae.12451. Epub 2014 May 8.

15.

Head-to-head comparison of the pharmacokinetic profiles of a high-purity factor IX concentrate (AlphaNine®) and a recombinant factor IX (BeneFIX®) in patients with severe haemophilia B.

Lissitchkov T, Matysiak M, Zavilska K, Laguna P, Gercheva L, Antonov A, Moret A, Caunedo P, Aznar JA, Woodward MK, Páez A.

Haemophilia. 2013 Sep;19(5):674-8. doi: 10.1111/hae.12148. Epub 2013 May 7.

PMID:
23647607
16.

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
17.

Population pharmacokinetics of recombinant factor IX: implications for dose tailoring.

Björkman S.

Haemophilia. 2013 Sep;19(5):753-7. doi: 10.1111/hae.12188. Epub 2013 Jun 4.

PMID:
23731351
18.

Population pharmacokinetics of sifalimumab, an investigational anti-interferon-α monoclonal antibody, in systemic lupus erythematosus.

Narwal R, Roskos LK, Robbie GJ.

Clin Pharmacokinet. 2013 Nov;52(11):1017-27. doi: 10.1007/s40262-013-0085-2.

19.

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

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