选择性人源单克隆抗体贝洛托单抗抗难辨梭菌感染复发2项关键Ⅲ期临床试验达主终点

发布时间：2018-03-29 18:02

  本文选题：Ⅲ期临床试验　切入点：贝洛　出处：《国际药学研究杂志》2015年06期

【摘要】：正默克公司宣布贝洛托单抗(bezlotoxumab)抗难辨梭菌感染复发的2项关键性Ⅲ期临床试验达到主终点,1次静脉注射12周后,较安慰剂降低了该菌感染复发率。这2次全球Ⅲ期、双盲试验评价该药单药或与阿托单抗伍用预防难辨梭菌感染复发,临床MODIFYⅠ试验涉及19个国家1452名患者(平均65岁);临床MODIFYⅡ试验涉及17个国家1203名患者(平均67岁)。MODIFYⅠ试验中患者除标准抗生素治疗外,随
[Abstract]:Merck announced that two critical phase III clinical trials against the recurrence of Clostridium dystoides by Belotumab decreased the rate of recurrence of Clostridium Reflex infection 12 weeks after a single intravenous injection at the primary end point, compared with placebo. Double blind test was used to evaluate the single drug or the combination with Atto monoclonal antibody to prevent the recurrence of Clostridium Refractoris infection. The clinical MODIFY 鈪，

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