A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

NCT05690711 | Completed Phase 2

• 1 other identifier: HRS8179-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The change between baseline and 72-78 hours in midline shift measured by MRI or CT

  Baseline up to 72 hours

Secondary Outcomes (4)

• modified Rankin Scale (mRS) Score

  Day 90

• Overall survival

  Baseline up to Day 90

• Number of Participants Who Achieved mRS 0-4

  Day 90

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to Day 90

Study Arms (2)

HRS8179

EXPERIMENTAL

Drug: HRS8179

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS8179 DRUG

HRS8179 injection

HRS8179

Placebo DRUG

physiological saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand and voluntarily participate in this research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative);
• Aged 18\~80, regardless of gender;
• A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
• NIHSS ≥ 10 points at screening;
• A large hemispheric infarction is defined as: lesion volume of 80 to 300 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
• The study drug initiated must be no later than 10 hours when stroke onset;

You may not qualify if:

• The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.3. There are clinical signs of brain hernia;
• CT/MRI suggested that the anterior septal/pineal excursion was \>2 mm due to brain edema;
• CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Brain Edema

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 19, 2023
• Study Start: April 7, 2023
• Primary Completion: December 5, 2023
• Study Completion: February 27, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-05

Locations

CN (1)