Brain Swelling, Large Hemispheric InfarctionPhase 2NCT05690711
A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction
A Phase 2 study testing HRS8179 in people with Brain Swelling, Large Hemispheric Infarction, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Swelling, Large Hemispheric Infarction
- What is being tested?
- HRS8179
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2023to 27 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 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;
Who cannot join
- The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere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);
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: 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.
- Being tested
- HRS8179, Placebo
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS8179Drug
HRS8179 injection
PlaceboDrug
physiological saline
| Study group | Role | What they receive |
|---|---|---|
| HRS8179 | Experimental | Not described Receives: Drug: HRS8179 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change between baseline and 72-78 hours in midline shift measured by MRI or CT
Measured: Baseline up to 72 hours
Secondary outcomes (4)
modified Rankin Scale (mRS) Score
Measured: Day 90
Overall survival
Measured: Baseline up to Day 90
Number of Participants Who Achieved mRS 0-4
Measured: Day 90
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start7 Apr 2023
- Primary completion5 Dec 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Swelling, 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
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
- NCT05690711
- Sponsor's protocol ID
- HRS8179-201
- Status last verified
- May 2024
- First submitted
- 27 Dec 2022
- Last updated
- 6 Jan 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT05690711
- Acronym / sponsor ID
- HRS8179-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 19 Jan 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS8179 | Experimental | Drug: HRS8179 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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);
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 |
|---|---|---|
| HRS8179HRS8179 injection | Drug | HRS8179 |
| Placebophysiological saline | Drug | Placebo |
Primary outcome
The change between baseline and 72-78 hours in midline shift measured by MRI or CT
Time frame: Baseline up to 72 hours
4 secondary outcomes
modified Rankin Scale (mRS) Score
Time frame: Day 90
Overall survival
Time frame: Baseline up to Day 90
Number of Participants Who Achieved mRS 0-4
Time frame: Day 90
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Swelling, Large Hemispheric Infarction
Recruiting
Early Prophylactic Decompressive Hemicraniectomy Following Endovascular Therapy in Large Hemispheric Infarct Trial
Stroke, Ischemic, Cerebral Edema
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS8179 in people with Brain Swelling, 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 6 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: finished, as of the sponsor's last update on 6 Jan 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change between baseline and 72-78 hours in midline shift measured by MRI or CT (time frame: Baseline up to 72 hours). 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 6 Jan 2025.