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Efficacy of EHL N9-GP for on-demand treatment of bleeding episodes in hemophilia B: analysis of pivotal trial data.

作者信息

Escobar Miguel A, Walsh Christopher E, Cooper David L, Young Guy

机构信息

Department of Internal Medicine, University of Texas Health Science Center at Houston-McGovern Medical School, Houston, TX, USA.

Icahn School of Medicine at Mount Sinai , New York, NY, USA.

出版信息

J Blood Med. 2019 Jul 25;10:243-250. doi: 10.2147/JBM.S212690. eCollection 2019.

DOI:10.2147/JBM.S212690
PMID:31413650
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6662862/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80dd/6662862/68dc02d0f6fb/JBM-10-243-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80dd/6662862/68dc02d0f6fb/JBM-10-243-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80dd/6662862/68dc02d0f6fb/JBM-10-243-g0001.jpg

相似文献

1
Efficacy of EHL N9-GP for on-demand treatment of bleeding episodes in hemophilia B: analysis of pivotal trial data.EHL N9-GP按需治疗B型血友病出血发作的疗效：关键试验数据分析
J Blood Med. 2019 Jul 25;10:243-250. doi: 10.2147/JBM.S212690. eCollection 2019.
2
Once-weekly prophylaxis with 40 IU/kg nonacog beta pegol (N9-GP) achieves trough levels of >15% in patients with haemophilia B: Pooled data from the paradigm™ trials.每周一次给予 40IU/kg 非活化凝血因子 IX 聚乙二醇复合物（N9-GP）可使乙型血友病患者达到 >15%的谷浓度：来自 paradigm™试验的汇总数据。
Haemophilia. 2018 Nov;24(6):911-920. doi: 10.1111/hae.13608. Epub 2018 Sep 24.
3
FIXing postinfusion monitoring: Assay experiences with N9-GP (nonacog beta pegol; Refixia ; Rebinyn ).固定输注后监测：N9-GP（非那西普贝洛；瑞百安；Rebinyn）的检测经验。
Haemophilia. 2019 Jan;25(1):154-161. doi: 10.1111/hae.13671.
4
Long-Term Safety and Efficacy of Nonacog Beta Pegol (N9-GP) Administered for at Least 5 Years in Previously Treated Children with Hemophilia B.长期接受非活化凝血因子 IX 聚乙二醇（N9-GP）治疗的乙型血友病患儿至少 5 年的安全性和疗效。
Thromb Haemost. 2020 May;120(5):737-746. doi: 10.1055/s-0040-1709521. Epub 2020 May 5.
5
Pharmacokinetics of a novel extended half-life glycoPEGylated factor IX, nonacog beta pegol (N9-GP) in previously treated patients with haemophilia B: results from two phase 3 clinical trials.一种新型延长半衰期的聚乙二醇化凝血因子IX（非阿考β-聚乙二醇，N9-GP）在既往接受治疗的B型血友病患者中的药代动力学：两项3期临床试验结果
Haemophilia. 2017 Jul;23(4):547-555. doi: 10.1111/hae.13191. Epub 2017 Feb 24.
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Defining the impact of hemophilia: the Academic Achievement in Children with Hemophilia Study.界定血友病的影响：血友病患儿学业成就研究
Pediatrics. 2001 Dec;108(6):E105. doi: 10.1542/peds.108.6.e105.
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Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety and efficacy extension trial (paradigm™4).乙型血友病中的聚乙二醇化重组人凝血因子IX（N9-GP）：一项多国III期安全性和疗效扩展试验（PARADIGM™4）
Thromb Res. 2016 May;141:69-76. doi: 10.1016/j.thromres.2016.02.030. Epub 2016 Mar 2.
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Extended Half-Life Coagulation Factors: A New Era in the Management of Hemophilia Patients.延长半衰期凝血因子：血友病患者管理的新时代。
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Factor IX-deficient plasma spiked with N9-GP behaves similarly to N9-GP post-administration clinical samples in N9-GP ELISA and FIX activity assays.添加了N9-GP的IX因子缺乏血浆在N9-GP ELISA和FIX活性测定中，其表现与N9-GP给药后的临床样本相似。
Haemophilia. 2015 Nov;21(6):832-6. doi: 10.1111/hae.12680. Epub 2015 Apr 30.
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Real-World Analysis of Dispensed International Units of Coagulation Factor VIII and Resultant Expenditures for Hemophilia A Patients: A Comparison Between Standard Half-Life and Extended Half-Life Products.血友病A患者凝血因子VIII国际单位配用量及相关支出的真实世界分析：标准半衰期产品与延长半衰期产品的比较
Manag Care. 2018 Oct;27(10):39-50.

本文引用的文献

1
The frequency of joint hemorrhages and procedures in nonsevere hemophilia A vs B.非重度血友病 A 与 B 患者关节出血和关节镜检查的频率。
Blood Adv. 2018 Aug 28;2(16):2136-2144. doi: 10.1182/bloodadvances.2018020552.
2
Impact of hemophilia B on quality of life in affected men, women, and caregivers-Assessment of patient-reported outcomes in the B-HERO-S study.血友病 B 对患病男性、女性及其照护者生活质量的影响——B-HERO-S 研究中患者报告结局的评估。
Eur J Haematol. 2018 Jun;100(6):592-602. doi: 10.1111/ejh.13055. Epub 2018 Apr 11.
3
Management of US men, women, and children with hemophilia and methods and demographics of the Bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S) study.
美国血友病男性、女性和儿童的管理以及“将血友病B的经验、结果和机会融入解决方案（B-HERO-S）”研究的方法和人口统计学特征。
Eur J Haematol. 2017 Apr;98 Suppl 86:5-17. doi: 10.1111/ejh.12854.
4
Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial.重组长效糖基化聚乙二醇化凝血因子IX用于治疗B型血友病：一项多国随机3期试验。
Blood. 2014 Dec 18;124(26):3880-6. doi: 10.1182/blood-2014-05-573055. Epub 2014 Sep 26.
5
Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX.人群药代动力学模型用于设定非活化凝血因子 IX 聚乙二醇（N9-GP）的剂量。
J Thromb Haemost. 2012 Nov;10(11):2305-12. doi: 10.1111/jth.12000.
6
Guidelines for the management of hemophilia.血友病管理指南。
Haemophilia. 2013 Jan;19(1):e1-47. doi: 10.1111/j.1365-2516.2012.02909.x. Epub 2012 Jul 6.
7
Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B.糖基化聚乙二醇化重组因子 IX 的增强药代动力学特性：在乙型血友病患者中的首次人体剂量试验。
Blood. 2011 Sep 8;118(10):2695-701. doi: 10.1182/blood-2011-02-335596. Epub 2011 May 9.
8
Analysis of low frequency bleeding data: the association of joint bleeds according to baseline FVIII activity levels.低频出血数据的分析：根据基线 FVIII 活性水平的关节出血关联。
Haemophilia. 2011 Jan;17(1):41-4. doi: 10.1111/j.1365-2516.2010.02383.x. Epub 2010 Sep 2.