The Efficacy and Safety of Intravenous HRS8179 for the Prevention and Treatment of Severe Cerebral Edema Following Large Hemispheric Infarction: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Trial
The study is being conducted to evaluate the efficacy, and safety of HRS8179 injection in preventing and treating severe cerebral edema after large area cerebral infarction in the cerebral hemisphere
注射用HRS8179治疗大面积缺血性脑卒中后严重脑水肿的有效性及安全性研究—多中心、随机、双盲、安慰剂对照、Ⅱ期临床试验
主要研究目的:评价注射用HRS8179治疗大面积缺血性脑卒中后严重脑水肿的影像学有效性;
次要研究目的:评价注射用HRS8179治疗大面积缺血性脑卒中的有效性;评价注射用HRS8179治疗大面积缺血性脑卒中的安全性;评价注射用HRS8179治疗大面积缺血性脑卒中的药代动力学特征。
Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial
The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.
100 项与 HRS-8179 相关的专利(医药)