Severe Cerebral Edema Following Large Hemispheric InfarctionPhase 2/3NCT06732648
The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction
A Phase 2/3 study testing HRS8179 injection and HRS8179 blank preparation. in people with Severe Cerebral Edema Following Large Hemispheric Infarction, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Cerebral Edema Following Large Hemispheric Infarction
- What is being tested?
- HRS8179 injection and HRS8179 blank preparation.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 725 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Liping Liu
About this study
Official title: 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
- Being tested
- HRS8179 injection, HRS8179 blank preparation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS8179 injectionDrug
HRS8179 injection; high dose
HRS8179 blank preparation.Drug
HRS8179 blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS8179 injection | Experimental | Not described Receives: Drug: HRS8179 injection |
| Treatment group B: HRS8179 injection | Experimental | Not described Receives: Drug: HRS8179 injection |
| Treatment group C: HRS8179 blank preparation. | Placebo comparator | Not described Receives: Drug: HRS8179 blank preparation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate at Day 90
Measured: at Day 90
Secondary outcomes (4)
The modified Rankin Scale (mRS) score at Day 90
Measured: at Day 90
The proportion of participants who achieved mRS score 0-4 at Day 90
Measured: at Day 90
Changes in midline shift from baseline to 72 hours
Measured: from baseline to 72 hours
The proportion of participants who meet the indications for decompressive craniectomy by Day 14
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start7 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Cerebral Edema Following Large Hemispheric InfarctionStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 725 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732648
- Sponsor's protocol ID
- HRS8179-301
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06732648
- Acronym / sponsor ID
- HRS8179-301
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 725 participants (estimated)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS8179 injection | Experimental | Drug: HRS8179 injection |
| Treatment group B: HRS8179 injection | Experimental | Drug: HRS8179 injection |
| Treatment group C: HRS8179 blank preparation. | Placebo comparator | Drug: HRS8179 blank preparation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
- The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS8179 injectionHRS8179 injection; high dose | Drug | Treatment group A: HRS8179 injection, Treatment group B: HRS8179 injection |
| HRS8179 blank preparation.HRS8179 blank preparation. | Drug | Treatment group C: HRS8179 blank preparation. |
Primary outcome
Mortality rate at Day 90
Time frame: at Day 90
4 secondary outcomes
The modified Rankin Scale (mRS) score at Day 90
Time frame: at Day 90
The proportion of participants who achieved mRS score 0-4 at Day 90
Time frame: at Day 90
Changes in midline shift from baseline to 72 hours
Time frame: from baseline to 72 hours
The proportion of participants who meet the indications for decompressive craniectomy by Day 14
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HRS8179 injection and HRS8179 blank preparation. in people with Severe Cerebral Edema Following Large Hemispheric Infarction, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Gao (0518-82342973, yu.gao.yg5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate at Day 90 (time frame: at Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.