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開拓藥業-B(09939.HK):普克魯胺治療輕中症新冠患者全球III期臨牀試驗完成中國首例受試者給藥
格隆匯 02-11 19:17

格隆匯2月11日丨開拓藥業-B(09939.HK)宣佈,於2022年2月10日,普克魯胺治療輕中症新冠患者全球多中心III期臨牀試驗(NCT04869228)已在深圳市第三人民醫院完成中國首例受試者入組及給藥("III期臨牀試驗")。

III期臨牀試驗是一項隨機、雙盲、安慰劑對照、全球多中心的研究,旨在探索普克魯胺治療輕中症新冠男性患者的有效性和安全性。目前該項試驗已經在巴西、菲律賓和馬來西亞等國家完成近200例受試者入組。中國是這項III期臨牀試驗的主要參與國之一,中國國家藥品監督管理局(NMPA)已於2021年9月1日批准這項臨牀試驗。目前中國參加該臨牀研究的中心包括北京地壇醫院、中日友好醫院、深圳市第三人民醫院、上海市公共衞生臨牀中心、杭州市西溪醫院、成都市公共衞生臨牀中心和蘇州市第五人民醫院等。

此外,普克魯胺針對重症住院新冠患者的臨牀試驗(NCT05009732)已在美國、烏克蘭、菲律賓全面啟動患者入組,目前正在中國臨牀中心進行患者入組前的篩選。其他參與全球多中心臨牀試驗國家的相關工作也在積極推進中

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