A Phase 2 interventional study of HRS8179 and Placebo in Brain Swelling, Large Hemispheric Infarction, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2, Interventional, and Treatment
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.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 62 interventional studies indexed under Brain Edema.
Browse Brain Edema studies →Beijing Suncadia Pharmaceuticals Co., Ltd is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HRS8179
Drug: Placebo
HRS8179 injection
physiological saline
The change between baseline and 72-78 hours in midline shift measured by MRI or CT
Time frame: Baseline up to 72 hours
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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