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A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

NCT05690711 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-06

No results posted yet for this study

Summary

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.

Conditions

  • Brain Swelling, Large Hemispheric Infarction

Interventions

DRUG

HRS8179

HRS8179 injection

DRUG

Placebo

physiological saline

Sponsors & Collaborators

  • Beijing Suncadia Pharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-07
Primary Completion
2023-12-05
Completion
2024-02-27

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690711 on ClinicalTrials.gov