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Long‐term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: Results from the B‐YOND extension study
Pasi, K. John, Fischer, Kathelijn, Ragni, Margaret, Kulkarni, Roshni, Ozelo, Margareth C., Mahlangu, Johnny, Shapiro, Amy, P’Ng, Stephanie, Chambost, Hervé, Nolan, Beatrice, Bennett, Carolyn, Matsushita, Tadashi, Winding, Bent, Fruebis, Joachim, Yuan, Huixing, Rudin, Dan, Oldenburg, Johannes
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.11.2020)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.11.2020)
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Journal Article
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, Jerry S., Apte, Shashikant, Chambost, Hervé, Hermans, Cedric, Jackson, Shannon, Josephson, Neil C., Mahlangu, Johnny N., Ozelo, Margareth C., Peerlinck, Kathelijne, Pasi, John, Perry, David, Ragni, Margaret V., Wang, Xuefeng, Jiang, Haiyan, Li, Shuanglian, Cristiano, Lynda M., Innes, Alison, Nugent, Karen, Brennan, Aoife, Luk, Alvin, Allen, Geoffrey, Pierce, Glenn F., Robinson, Brian
Published in British journal of haematology (01.01.2015)
Published in British journal of haematology (01.01.2015)
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Journal Article
Pharmacokinetic parameters of recombinant factor IX Fc fusion protein are not influenced by factor IX antigen levels in subjects from the Phase 3 B‐LONG trial
Sidonio, Robert F., Casiano, Sandra, Falk, Aletta, Altincatal, Arman, Katragadda, Suresh, Santagostino, Elena, Windyga, Jerzy
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2023)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2023)
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Journal Article
Matching-Adjusted Indirect Comparison of Recombinant Factor IX Albumin Fusion Protein Versus Recombinant Factor IX Fc Fusion Protein for Weekly Prophylactic Treatment of Hemophilia B
Guillet, Benoit, Yan, Songkai, Hooper, Becky, Drelich, Douglass, Steenkamp, Jason, Tomic, Radovan, Mancuso, Maria Elisa
Published in Advances in therapy (01.02.2024)
Published in Advances in therapy (01.02.2024)
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Journal Article
Prophylaxis with recombinant factor IX Fc fusion protein reduces the risk of bleeding and delays time to first spontaneous bleed event in previously untreated patients with haemophilia B: A post hoc analysis of the PUPs B‐LONG study
Nolan, Beatrice, Recht, Michael, Rendo, Pablo, Falk, Aletta, Foster, Meredith, Casiano, Sandra, Rauch, Antoine, Shapiro, Amy
Published in European journal of haematology (01.10.2024)
Published in European journal of haematology (01.10.2024)
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Journal Article
Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients
Shapiro, Amy D., Ragni, Margaret V., Valentino, Leonard A., Key, Nigel S., Josephson, Neil C., Powell, Jerry S., Cheng, Gregory, Thompson, Arthur R., Goyal, Jaya, Tubridy, Karen L., Peters, Robert T., Dumont, Jennifer A., Euwart, Donald, Li, Lian, Hallén, Bengt, Gozzi, Peter, Bitonti, Alan J., Jiang, Haiyan, Luk, Alvin, Pierce, Glenn F.
Published in Blood (19.01.2012)
Published in Blood (19.01.2012)
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Journal Article
Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B
Pasi, K John, Fischer, Kathelijn, Ragni, Margaret, Nolan, Beatrice, Perry, David J, Kulkarni, Roshni, Ozelo, Margareth, Mahlangu, Johnny, Shapiro, Amy D, Baker, Ross I, Bennett, Carolyn M, Barnes, Christopher, Oldenburg, Johannes, Matsushita, Tadashi, Yuan, Huixing, Ramirez-Santiago, Alejandra, Pierce, Glenn F, Allen, Geoffrey, Mei, Baisong
Published in Thrombosis and haemostasis (2017)
Published in Thrombosis and haemostasis (2017)
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Journal Article
Post hoc longitudinal assessment of the efficacy and safety of recombinant factor IX Fc fusion protein in hemophilia B
Shapiro, Amy D., Kulkarni, Roshni, Ragni, Margaret V., Chambost, Hervé, Mahlangu, Johnny, Oldenburg, Johannes, Nolan, Beatrice, Ozelo, Margareth C., Foster, Meredith C., Willemze, Annemieke, Barnowski, Christopher, Jain, Nisha, Winding, Bent, Dumont, Jennifer, Lethagen, Stefan, Barnes, Chris, Pasi, K. John
Published in Blood advances (11.07.2023)
Published in Blood advances (11.07.2023)
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Journal Article
Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates
Powell, Jerry, Shapiro, Amy, Ragni, Margaret, Negrier, Claude, Windyga, Jerzy, Ozelo, Margareth, Pasi, John, Baker, Ross, Potts, James, Li, Shuanglian, Mei, Baisong, Pierce, Glenn F., Robinson, Brian
Published in British journal of haematology (01.01.2015)
Published in British journal of haematology (01.01.2015)
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Journal Article
Long Term Safety and Efficacy of Recombinant Factor IX Fc Fusion Protein (rFIXFc) Prophylaxis in Children with Hemophilia B: Interim Results of the B-Yond Extension Study
Ducore, Jonathan M., Fischer, Kathelijn, Kulkarni, Roshni, Nolan, Beatrice, Bennett, Carolyn M., Perry, David J, Yuan, Huixing, Ramirez-Santiago, Alejandra, Ferrante, Francesca, Lethagen, Stefan
Published in Blood (02.12.2016)
Published in Blood (02.12.2016)
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Journal Article
Clinical Outcomes in Adults/Adolescents with Hemophilia B Treated Long Term with Recombinant Factor IX Fc Fusion Protein (rFIXFc) Prophylaxis: Interim Results of the B-Yond Extension Study
Matsushita, Tadashi, Mahlangu, Johnny, Shapiro, Amy D, Pasi, K John, Ragni, Margaret V., Ozelo, Margareth C, Oldenburg, Johannes, Baker, Ross I, Yuan, Huixing, Ramirez-Santiago, Alejandra, Ferrante, Francesca, Lethagen, Stefan
Published in Blood (02.12.2016)
Published in Blood (02.12.2016)
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Journal Article
Low Bleeding Rates with Increase or Maintenance of Physical Activity in Patients Treated with Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the B-LONG and Kids B-LONG Studies
Kulkarni, Roshni, Shapiro, Amy D, Windyga, Jerzy, Ragni, Margaret V, Pasi, K John, Ozelo, Margareth Castro, Tsao, Elisa, Mei, Baisong
Published in Blood (03.12.2015)
Published in Blood (03.12.2015)
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Journal Article
Pharmacokinetics, Safety, and Efficacy Of Long-Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) In Adolescent Subjects With Hemophilia B: A Subgroup Analysis Of The B-LONG Study
Shapiro, Amy, Pasi, John, Mahlangu, Johnny, Perry, David J., Powell, Jerry S, Ragni, Margaret V., Valentino, Leonard A., Ozelo, Margareth, Nugent, Karen, Li, Shuanglian, Brennan, Aoife, Pierce, Glenn F, Allen, Geoffrey
Published in Blood (15.11.2013)
Published in Blood (15.11.2013)
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Journal Article
Pharmacokinetics Of Recombinant Factor IX Fc Fusion Protein (rFIXFc) In Pediatric Subjects With Hemophilia B: An Interim Analysis Of The Kids B-LONG Study
Fischer, Kathelijn, Kulkarni, Roshni, Bradbury, Myles, Ragni, Margaret V., Rangarajan, Savita, Dong, Yingwen, Li, Shuanglian, Jiang, Haiyan, Nugent, Karen, Pierce, Glenn F, Allen, Geoffrey
Published in Blood (15.11.2013)
Published in Blood (15.11.2013)
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Journal Article
Association Of Bleeding Tendency With Time Under Target FIX Activity Levels In Severe Hemophilia B Patients Treated With Recombinant Factor IX Fc Fusion Protein
Shapiro, Amy, Potts, James, Li, Shuanglian, Valentino, Leonard A., Diao, Lei, Wang, Ping, Robinson, Brian, Pierce, Glenn F, Jiang, Haiyan
Published in Blood (15.11.2013)
Published in Blood (15.11.2013)
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Journal Article
Clinical Outcomes in Adults/Adolescents with Hemophilia B Treated Long Term with Recombinant Factor IX Fc Fusion Protein (rFIXFc) Prophylaxis: Interim Results of the B-Yond Extension Study
Alejandra Ramirez-Santiago, Amy D. Shapiro, Margareth C. Ozelo, K. John Pasi, Ross I. Baker, Margaret V. Ragni, Huixing Yuan, Johannes Oldenburg, Stefan Lethagen, Johnny Mahlangu, Francesca Ferrante, Tadashi Matsushita
Published in Blood (02.12.2016)
Published in Blood (02.12.2016)
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Journal Article
Investigators at Biogen Idec, Inc. Describe Findings in Blood Coagulation Factors
Published in Biotech Week
(14.01.2015)
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Newsletter
Recombinant factor IX Fc for major surgery in hemophilia B: factor IX plasma activity levels and effective hemostasis
Shapiro, Amy D., Chambost, Hervé, Ozelo, Margareth C., Falk, Aletta, Ahlin, Helena, Casiano, Sandra, Santagostino, Elena
Published in Research and practice in thrombosis and haemostasis (01.08.2023)
Published in Research and practice in thrombosis and haemostasis (01.08.2023)
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Journal Article