博暉創新(300318.SZ):人凝血因子Ⅷ獲批藥物臨牀試驗
格隆匯5月25日丨博暉創新(300318.SZ)公佈,公司控股子公司河北大安製藥有限公司(“大安製藥”)研發的人凝血因子VIII於近日獲得了國家藥品監督管理局頒發的《藥物臨牀試驗批准通知書》。
臨牀試驗開展前,請申請人與研究者討論,進一步修訂完善本品臨牀試驗方案,建議如下:1、PK 試驗:先完成至少12 例受試者單次給藥PK 試驗再進行按需治療研究,以便根據PK 試驗結果設置有效性研究的活性回收率採樣時間點;完成PK 試驗的受試者可繼續進行按需治療研究;請明確PK 試驗期間若受試者發生出血的治療方案。2、主要療效指標:根據止血療效四級評分量表,止血療效評價時間點至少應包括每次出血治療第1 次給藥後的8hr和72hr。3、因子VIII抑制物:(1)為避免因輸注因子VIII而影響低水平抑制物的發現,建議在抑制物檢測用血樣採集前至少48h 不輸注因子VIII,以保證至少5 個半衰期的洗脱期;(2)中心實驗室應對抑制物進行及時檢測,不可將首次用藥後第90天的抑制物檢測放在180 天檢測,以便及早發現抑制物發生情況;(3)若檢測到抑制物,建議在1-4 周內再次檢測抑制物;(4)明確受試者出現抑制物時的治療措施。4、本臨牀試驗納入的受試者為先天性血友病A 患者,建議刪除方案中獲得性因子VIII抑制物增多症的適應症及相關給藥方案。
臨牀試驗期間,申請人可就試驗中相關問題向藥品審評中心提出溝通交流會議申請。
本項臨牀試驗應當在批准之日起3 年內實施,逾期未實施的,本件自行廢止。
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