1.药代动力学试验主要目的 1）通过单次给药的药代动力学（PK）试验，评价人凝血因子Ⅷ/血管性血友病因子复合物在血管性血友病患者中的PK特征。 2）观察和评价药代动力学（PK）试验期间安全性，包括临床症状体征和实验室指标，并分析不良事件的发生率和严重程度。试验期间重点监测血栓相关风险以及观察用药结束后72h内的不良事件和给药部位的局部不良反应。次要目的评价人凝血因子Ⅷ/血管性血友病因子复合物单次给药的增量回收率，为临床给药剂量的计算提供确定依据。 2. 临床疗效期试验主要目的评价血管性血友病患者采用人凝血因子Ⅷ/血管性血友病因子复合物按需治疗出血事件的临床有效性及安全性，为上市许可申请提供依据。次要目的 1）采用其他临床次要疗效指标，进一步观察和评价人凝血因子Ⅷ/血管性血友病因子复合物治疗出血事件的临床有效性。 2）观察和评价试验期间安全性，包括临床症状体征和实验室指标，并分析不良事件的发生率和严重程度。试验期间重点监测血栓相关风险以及观察每次用药结束后的不良事件和给药部位的局部不良反应。

开始日期-

申办/合作机构

山东泰邦生物制品有限公司

100 项与人凝血因子Ⅷ/血管性血友病因子复合物（山东泰邦）相关的临床结果

登录后查看更多信息

100 项与人凝血因子Ⅷ/血管性血友病因子复合物（山东泰邦）相关的转化医学

登录后查看更多信息

100 项与人凝血因子Ⅷ/血管性血友病因子复合物（山东泰邦）相关的专利（医药）

登录后查看更多信息

项与人凝血因子Ⅷ/血管性血友病因子复合物（山东泰邦）相关的文献（医药）

2021-01-01·BMJ Case Reports

Acquired von Willebrand syndrome in association with multiple myeloma: remission after stem cell transplant

Article

作者: Delaune, Jess ; Shah, Chintan P ; Mandernach, Molly W

Acquired von Willebrand syndrome is a rare bleeding disorder characterised by a later age of onset without a personal or family history of bleeding diathesis. It is vital to discern acquired von Willebrand syndrome from inherited von Willebrand disease and other acquired bleeding disorders as management differs significantly. Acquired von Willebrand syndrome is usually secondary to an underlying disorder such as lymphoproliferative disorder, myeloproliferative neoplasm, solid tumour, cardiovascular disorder, autoimmune disorders or hypothyroidism. Diagnosis is often delayed with a significant risk of morbidity and even mortality. Here we present a case of a 74-year-old man with an acquired bleeding disorder and work up suggestive of acquired von Willebrand syndrome secondary to immunoglobulin G kappa multiple myeloma. He was treated successfully with intravenous immunoglobulin, von Willebrand Factor/Coagulation Factor VIII Complex (human), myeloma directed chemotherapy and autologous stem cell transplantation. We also discuss the management strategies that are largely based on retrospective studies and case reports.

Drugs in Context

Human plasma-derived FVIII/VWD concentrate (Biostate): a review of experimental and clinical pharmacokinetic, efficacy and safety data

Review

作者: Favaloro, Emmanuel J ; Harper, Paul ; Curtin, Julie ; Barnes, Chris ; Dunkley, Scott

Human plasma-derived factor VIII/von Willebrand factor complex concentrates are used to control bleeding in patients with von Willebrand disease (VWD) or haemophilia A (HA). The properties of these haemostatic factor concentrates vary widely, which can have significant clinical implications. This review provides an extensive overview of the molecular properties, in addition to pharmacokinetic, efficacy and safety data, and case studies of clinical experience of one such concentrate, Biostate. These data are discussed in the context of various therapeutic applications and compared with other factor concentrate products. Data are presented from data on file from the manufacturer; product information and published experimental and clinical pharmacokinetic, safety and efficacy study data; and example case studies of clinical experience. The data discussed herein demonstrate that Biostate has well-established efficacy profiles in the treatment of patients with VWD or HA, with the control of bleeding rated as 'excellent', 'good' or 'moderate' in >90% of patients. In an immune-tolerance induction setting, 73% of patients achieved a complete response following treatment with Biostate. Biostate was generally well tolerated in patients with HA or VWD, with infrequent minor adverse events reported and no reported cases of clinically relevant thrombosis.

100 项与人凝血因子Ⅷ/血管性血友病因子复合物（山东泰邦）相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
获得性凝血因子缺乏	临床3期	中国	山东泰邦生物制品有限公司	2022-11-18
获得性血友病	临床3期	中国	山东泰邦生物制品有限公司	2022-11-18
血友病A	临床3期	中国	山东泰邦生物制品有限公司	2022-11-18
出血	临床3期	中国	山东泰邦生物制品有限公司	2022-11-18
冯·维勒布兰德病	临床3期	中国	山东泰邦生物制品有限公司	2022-11-18