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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
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
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
Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients
Collins, P. W., Quon, D. V. K., Makris, M., Chowdary, P., Kempton, C. L., Apte, S. J., Ramanan, M. V., Hay, C. R. M., Drobic, B., Hua, Y., Babinchak, T. J., Gomperts, E. D.
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2018)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2018)
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Journal Article
Recombinant factor IX (BAX326) in previously treated paediatric patients with haemophilia B: a prospective clinical trial
Urasinski, T., Stasyshyn, O., Andreeva, T., Rusen, L., Perina, F. G., Oh, M. S., Chapman, M., Pavlova, B. G., Valenta-Singer, B., Abbuehl, B. E.
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.03.2015)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.03.2015)
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Journal Article
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, J. L., Oh, M.-S., Chapman, M., Fritsch, S., Pavlova, B. G., Wong, W.-Y., Abbuehl, B. E.
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2014)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2014)
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Journal Article
In silico evaluation of limited blood sampling strategies for individualized recombinant factor IX prophylaxis in hemophilia B patients
Preijers, T., Hazendonk, H. C. A. M., Fijnvandraat, K., Leebeek, F. W. G., Cnossen, M. H., Mathôt, R. A. A.
Published in Journal of thrombosis and haemostasis (01.09.2017)
Published in Journal of thrombosis and haemostasis (01.09.2017)
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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
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
Efficacy and safety of a recombinant factor IX (Bax326) in previously treated patients with severe or moderately severe haemophilia B undergoing surgical or other invasive procedures: a prospective, open-label, uncontrolled, multicentre, phase III study
Windyga, J., Lissitchkov, T., Stasyshyn, O., Mamonov, V., Ghandehari, H., Chapman, M., Fritsch, S., Wong, W.-Y., Pavlova, B. G., Abbuehl, B. E.
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.09.2014)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.09.2014)
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Journal Article
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
Improvement in health-related quality of life with recombinant factor IX prophylaxis in severe or moderately severe haemophilia B patients: results from the BAX326 Pivotal Study
Windyga, J., Lin, V. W., Epstein, J. D., Ito, D., Xiong, Y., Abbuehl, B. E., Ramirez, J. H.
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.05.2014)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.05.2014)
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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