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    THERAPY FOR TREATMENT OR PREVENTION OF CONDITIONS ASSOCIATED WITH BLEEDING OR HYPOCOAGULATION
    86.
    发明公开
    THERAPY FOR TREATMENT OR PREVENTION OF CONDITIONS ASSOCIATED WITH BLEEDING OR HYPOCOAGULATION 审中-公开
    THERAPIE ZUR BEHANDLUNG ODER VORBEUGUNG VON MIT BLUTUNGEN ODER HYPOKOAGULATION ASSOZIIERTEN LEIDEN

    公开(公告)号：EP3065768A4

    公开(公告)日：2017-07-19

    申请号：EP14856815

    申请日：2014-11-04

    申请人： UNIV CALIFORNIA ,  SCRIPPS RESEARCH INST

    发明人： VON DRYGALSKI ANNETTE ,  GALE ANDREW ,  GRIFFIN JOHN H ,  MOSNIER LAURENT

    IPC分类号： A61K38/36 ,  A61K38/48 ,  A61K45/06 ,  A61P7/04 ,  C07K14/745

    CPC分类号： C07K14/745 ,  A61K38/36 ,  A61K38/4846 ,  A61K45/06 ,  C12Y304/21021

    摘要： The present application generally relates to methods to prevent or treat bleeding and/or hypocoagulation in an individual in need thereof, and compositions for use in such methods. The methods comprise administration of FVa, preferably an APC resistant FVa (such as superFVa), alone or in combination with FVIIa, preferably rhFVIIa (such as NovoSeven® or another FVIIa having enhanced activity or half-life). When administered in combination, FVa and FVIIa elicit a synergistic benefit when used to treat or prevent bleeding or hypocoagulation in subjects in need thereof, e.g., subjects with a genetic disorder such as hemophilia or an acquired bleeding disorder or other condition associated with bleeding or hypocoagulation such as hemorrhagic stroke or shock, trauma, surgery or dysmenorrhea or individuals who produce inhibitory antibodies against procoagulants such as FVIII or FIX or who have been administered an overdose of an anticoagulant drug such as a direct Xa or direct thrombin inhibitor or a Novel Oral Anti-Coagulant (NOAC) or demonstrate unexplained bleeding. Also, the invention relates to the use of a superFVa alone or in combination with FVIIa or other procoagulant or prohemostatic agent to prevent, treat or reverse APC-associated bleeding, e.g., as the result of APC overproduction (such as through serious injury and/or hemorrhagic shock) or APC or other anticoagulant therapy, e.g., in the treatment of inflammatory disorders or sepsis disease.

    摘要翻译： 本申请一般涉及预防或治疗有需要的个体的出血和/或低凝血的方法，以及用于这种方法的组合物。 所述方法包括单独或与FVIIa，优选rhFVIIa（例如具有增强的活性或半衰期的另一种FVIIa）组合施用FVa，优选APC抗性FVa（诸如superFVa）。 当组合施用时，FVa和FVIIa在用于治疗或预防有需要的受试者（例如具有遗传病症例如血友病或获得性出血病症或与出血或凝血过程相关的其它病症的受试者）中的出血或低凝时引起协同益处 例如出血性中风或休克，创伤，手术或痛经或产生针对促凝血剂如FVIII或FIX的抑制性抗体的个体，或者已经施用过量抗凝血药物如直接Xa或直接凝血酶抑制剂或新型口服抗体 凝血剂（NOAC）或证明不明原因的出血。 而且，本发明涉及单独使用superFVa或与FVIIa或其他促凝血剂或止血剂联合使用以预防，治疗或逆转APC相关的出血，例如由于APC过度产生（例如通过严重损伤和/ 或失血性休克）或​​APC或其他抗凝剂治疗，例如治疗炎性疾病或败血症疾病。