一个开放研究的长期安全性和有效性评估lanadelumab攻击的预防遗传性血管性水肿:设计的帮助研究扩展。

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Riedl马,伯恩斯坦是的,纳杰,克雷格•T Magerl M, Cicardi M, Longhurst HJ, Shennak MM,杨WH Schranz J,巴普蒂斯塔J,会先PJ

一个开放研究的长期安全性和有效性评估lanadelumab攻击的预防遗传性血管性水肿:设计的帮助研究扩展。

中国Transl过敏。2017年10月6日,36。doi: 10.1186 / s13601 - 017 - 0172 - 9。eCollection 2017。

PubMed ID

29043014 (在PubMed

]

文摘

背景:遗传性血管性水肿(已经)的特点是反复发作的皮下或粘膜下水肿。攻击是不可预测的,衰弱,对生活质量产生重大影响。患者可能规定的预防性治疗预防血管性水肿的攻击。目前预防性治疗可能很难管理(即。静脉注射),需要频繁的政府或不耐受良好,突破攻击可能仍然频繁发生。Lanadelumab subcutaneously-administered单克隆抗体的血浆激肽释放酶抑制剂在临床开发预防遗传性血管性水肿的攻击。1 b阶段研究支持它的功效在防止攻击。一个阶段3,随机、双盲、安慰剂对照、parallel-arm研究已经完成,一个非盲扩展目前正在进行。方法/设计:开放式扩展的主要目的是评估长期安全的患者反复皮下政府lanadelumab类型I / II有。二级目标包括评估的有效性和时间先血管性水肿攻击来确定剂量间隔的外边界。 The study will also evaluate immunogenicity, pharmacokinetics/pharmacodynamics, quality of life, characteristics of breakthrough attacks, ease of self-administration, and safety/efficacy in patients who switch to lanadelumab from another prophylactic therapy. The open-label extension will enroll patients who completed the double-blind study ("rollover patients") and those who did not participate in the double-blind study ("non-rollover patients"), which includes patients who may or may not be currently using another prophylactic therapy. Rollover patients will receive a single 300 mg dose of lanadelumab on Day 0 and the second dose after the patient's first confirmed angioedema attack. Thereafter, lanadelumab will be administered every 2 weeks. Non-rollover patients will receive 300 mg lanadelumab every 2 weeks regardless of the first attack. All patients will receive their last dose on Day 350 (maximum of 26 doses), and will then undergo a 4-week follow-up. DISCUSSION: Prevention of attacks can reduce the burden of illness associated with HAE. Prophylactic therapy requires extended, repeated dosing and the results of this study will provide important data on the long-term safety and efficacy of lanadelumab, a monoclonal antibody inhibitor of plasma kallikrein for subcutaneous administration for the treatment of HAE. Trial registration NCT02741596.

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药物靶点

药物	目标	类	生物	药理作用	行动
Lanadelumab	血浆激肽释放酶	蛋白质	人类	是的	抑制剂 监管机构	细节