【摘 要】
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默克公司宣布用于骨髓移植预防巨细胞病毒()感染的期临床试验达到主终点。在骨髓移植后24周,试验未检出巨细胞病毒。关键的Ⅲ期临床试验入选>18岁、血浆中未能检出巨细胞病毒
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默克公司宣布用于骨髓移植预防巨细胞病毒()感染的期临床试验达到主终点。在骨髓移植后24周,试验未检出巨细胞病毒。关键的Ⅲ期临床试验入选>18岁、血浆中未能检出巨细胞病毒DNA者,按2∶1随机分到letermovir 480 mg/d组或安慰剂组,每日1次,直到骨髓移植后100 d。14~24周,每周1次确定主终点,即出现巨细胞病毒感染。主终点显示,495名给药受试者中letermovir组巨细胞病毒感染
Merck announces the main endpoint of clinical trials of bone marrow transplantation for the prevention of CMV infection. At 24 weeks after bone marrow transplantation, no cytomegalovirus was detected in the test. The key phase III trial was> 18 years old and failed to detect cytomegalovirus DNA in plasma. Patients were randomized to letermovir 480 mg / d or placebo at 2: 1 once daily until bone marrow transplantation 100 d. 14 to 24 weeks, once a week to determine the main endpoint, the emergence of cytomegalovirus infection. The primary endpoint showed cytomegalovirus infection in the letermovir group in 495 dosing subjects
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