Zobrazeno 1 - 10 of 11 pro vyhledávání: '"Nikki Church"'
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BAY 81‐8973 demonstrated efficacy, safety and joint status improvement in patients with severe haemophilia A in the LEOPOLD I extension for ≤2 years
Autor: Nikki Church, Despina Tseneklidou-Stoeter, Elena Santagostino, Shadan Lalezari, Johnny Mahlangu, Maria Fernanda Lopez Fernandez, Horst Beckmann
Publikováno v: European Journal of Haematology
Objectives BAY 81‐8973 (Kovaltry®), a full‐length, unmodified, recombinant human factor VIII, provided excellent bleeding control for patients with haemophilia A in the pivotal 1‐year LEOPOLD I trial. The LEOPOLD I extension evaluated long‐t
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9337a856d170e7aef97d873b01f72156
https://doi.org/10.1111/ejh.13402
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2
Validity and reliability of the Colorado Adult Joint Assessment Scale in adults with moderate‐severe hemophilia A
Autor: Olga Moshkovich, Dianne Thornhill, Brittany Gentile, Nikki Church, Sharon Funk, Marilyn J. Manco-Johnson, Sylvia Engelen, Katy Benjamin, Walter Hong
Publikováno v: Journal of Thrombosis and Haemostasis
Background The Colorado Adult Joint Assessment Scale (CAJAS) is designed to assess joint health in adults with hemophilia. The CAJAS comprises nine items (swelling, muscle atrophy, axial deformity, crepitus, range of motion, contracture, instability,
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31c1d2ad75266cd30f0d7cae83e778ac
https://doi.org/10.1111/jth.14651
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3
Efficacy and safety of prophylaxis with BAY 81‐8973 in Chinese patients with severe haemophilia A enrolled in the LEOPOLD II trial
Autor: Yongqiang Zhao, Despina Tseneklidou-Stoeter, Xuefeng Wang, Jing Sun, Renchi Yang, Nikki Church, Junde Wu, Depei Wu
Publikováno v: Haemophilia
Introduction BAY 81-8973 (Kovaltry® ) is a full-length, unmodified recombinant human factor VIII approved in China for prophylaxis and on-demand treatment in patients with haemophilia A. Limited access to FVIII prophylaxis in China has historically
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f1f4d65d731bf8260c836bf5454a02a4
http://europepmc.org/articles/PMC6850381
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4
Continued benefit demonstrated with BAY 81-8973 prophylaxis in previously treated children with severe haemophilia A: Interim analysis from the LEOPOLD Kids extension study
Autor: Victor S. Blanchette, Bryce A. Kerlin, Rolf Ljung, Nikki Church, Valentina Uscatescu, Sonata Saulytė Trakymienė, L. Rusen, Despina Tseneklidou-Stoeter, Horst Beckmann, Gili Kenet
Publikováno v: Thrombosis research, Kidlington : Pergamon-Elsevier Science Ltd., 2020, vol. 189, p. 96-101
Introduction BAY 81-8973 (Kovaltry®), a recombinant factor VIII (rFVIII) product, was efficacious and well tolerated in paediatric previously treated patients (PTPs) with severe haemophilia A for ≥50 exposure days (EDs) in the LEOPOLD Kids study.
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a711d7b9d4e4a7a7b1571ce30b248c3e
https://pubmed.ncbi.nlm.nih.gov/32197139
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5
Factor VIII activity of BAY 94-9027 is accurately measured with most commonly used assays: Results from an international laboratory study
Autor: Lilley Leong, Nikki Church, Lisa A. Michaels, I. Noerenberg, H.-F. Ulbrich, Steve Kitchen, Y. Katterle
Publikováno v: Haemophilia. 24:823-832
Introduction Discrepancies in the measurement of modified factor VIII (FVIII) products have been recognized, highlighting the need for adjustments in clinical laboratory practices to ensure effective monitoring of patients treated with these products
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4b1400c61c97cd6b609dd0c814beb4e7
https://doi.org/10.1111/hae.13564
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6
BAY 81-8973, a full-length recombinant factor VIII for the treatment of hemophilia A: product review
Autor: Lawrence H. Schwartz, Nikki Church, Anita Shah, Sanjay P Ahuja, Johnny Mahlangu, Jerzy Windyga
Publikováno v: Therapeutic Advances in Hematology. 9:191-205
BAY 81-8973 (Kovaltry®) is an unmodified, full-length recombinant factor VIII (rFVIII) approved for the prevention and treatment of bleeding episodes in patients with hemophilia A. The amino acid sequence for BAY 81-8973 is identical to that of sucr
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ea2e33fd1fbbe217360983101c08dc24
https://doi.org/10.1177/2040620718777903
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7
Matching-adjusted indirect comparisons of efficacy of BAY 81-8973 vs two recombinant factor VIII for the prophylactic treatment of severe hemophilia A
Autor: Jennifer Pocoski, Monika Maas Enriquez, Nanxin Li, Sneha S. Kelkar, Quer Xiang, Rajeev Ayyagari, Jipan Xie, Eric Q. Wu, Nikki Church, Ella X Du
Publikováno v: Journal of Blood Medicine
Jennifer Pocoski,1 Nanxin Li,2 Rajeev Ayyagari,2 Nikki Church,1 Monika Maas Enriquez,1 Quer Xiang,2 Sneha Kelkar,3 Ella X Du,2 Eric Q Wu,2 Jipan Xie3 1Bayer HealthCare Pharmaceuticals, Whippany, NJ, 2Analysis Group, Inc., Boston, MA, 3Analysis Group,
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e714c216d35e3e38cd2da326a89dfe94
https://www.dovepress.com/matching-adjusted-indirect-comparisons--of-efficacy-of-bay-81-8973-vs--peer-reviewed-article-JBM
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8
Bay 94-9027 Can be Accurately Measured across Regions with Appropriate One-Stage Assay Reagent Use
Autor: Nikki Church, Donna D. Castellone, Lilley Leong, Rajiv K. Pruthi, Steve Kitchen
Publikováno v: Blood. 132:2481-2481
Introduction: Differences in coagulation assay reagents may lead to variable results for some extended-half-life (EHL) recombinant factor VIII (rFVIII) products, with the potential to adversely affect patient care. Laboratories assessing EHL-rFVIII a
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::6d58122945084ef8e8f5448b90e05374
https://doi.org/10.1182/blood-2018-99-113493
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9
Rationale for Investigator-Assigned Prophylaxis Dosing Frequency in the Leopold I Study
Autor: Monika Maas Enriquez, Mia Yoon, Nikki Church, Shadan Lalezari, Lone Hvitfeldt Poulsen, Thomas J. Humphries
Publikováno v: Blood. 128:4984-4984
The LEOPOLD I study (part B) in severe hemophilia A was a multicenter, phase II/III, open-label trial to assess the safety, tolerability, and efficacy of prophylaxis treatment with BAY 81-8973, an unmodified recombinant factor VIII product. Dose and
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::8901fe3dfa9adf5d6746a6f7ec3c711e
https://doi.org/10.1182/blood.v128.22.4984.4984
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10
Bay 94-9027, a Site-Specifically Pegylated Recombinant Factor VIII: Preliminary Results from an International Comparative Laboratory Field Study
Autor: Stefan Bruns, Yadagiri Rao Danda, Iris Noerenberg, Lilley Leong, Nikki Church, Yvonne Katterle, Lisa A. Michaels, Hannes-Friedrich Ulbrich
Publikováno v: Blood. 128:2587-2587
Introduction: Accurate measurement of factor VIII (FVIII) in patients with hemophilia A after infusion of FVIII is important for patient monitoring and treatment decisions. Discrepancies in results using different assays or reagents to measure prolon
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0783c58d8844bd8cadc5491c70435150
https://doi.org/10.1182/blood.v128.22.2587.2587
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