The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this 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

Eligibility criteria

Qualifiers

Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative);

A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;

National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;

A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).

Disqualifiers

Theparticipant is likely to withdraw the supportive treatment on the first day;

There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.

There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2 mm; CT/MRI indicates cerebral hemorrhage;

Trial design

Treatments tested in this trial

  • HRS8179 injection
  • HRS8179 blank preparation.

Treatment groups

725 Participants
are divided into 3 treatment groups