Mallinckrodt的特利加压素达到1型肝肾综合症III期研究的主要目标

2019-08-16 不详 MedSci原创

Mallinckrodt宣布其特利加压素治疗1型肝肾综合症(HRS-1)成人患者的III期CONFIRM试验符合其主要终点和几乎所有预先指定的次要目标。这一消息促使股票周四上涨11%,该公司计划于明年初向FDA提交营销申请用于治疗。特利加压素是一种对V1受体具有选择性的加压素类似物。

Mallinckrodt宣布其特利加压素治疗1型肝肾综合症(HRS-1)成人患者的III期CONFIRM试验符合其主要终点和几乎所有预先指定的次要目标。这一消息促使股票周四上涨11%,该公司计划于明年初向FDA提交营销申请用于治疗。特利加压素是一种对V1受体具有选择性的加压素类似物。

该试验包括300名肝硬化和腹水的成人HRS-1患者,其肾功能迅速恶化且对利尿剂或白蛋白无反应。参与者随机接受静脉注射特利加压素或安慰剂。主要目标是在15天内验证HRS逆转,定义为连续两次血清肌酐值为1.5 mg / dL或更低的患者百分比。次要终点包括在14天时间内HRS逆转患者的发生率,以及在没有肾脏替代治疗的情况下维持HRS逆转至第30天的百分比。

Mallinckrodt指出,加拿大或美国目前尚未批准用于HRS-1的药物治疗,该病症每年影响约30000至40000名患者。

2015年Mallinckrodt以23亿美元收购 Ikaria获得了特利加压素。该药物目前已被许多国家批准为HRS-1的标准治疗药物。

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    2019-12-02 juliusluan78
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    2019-11-05 fyxzlh
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    2019-08-18 膀胱癌
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