Actively Recruiting
Study to Assess the Efficacy and Safety of QHRD106 Injection in Acute Ischemic Stroke.
Led by Changzhou Qianhong Bio-pharma Co., Ltd. · Updated on 2026-02-09
320
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the efficacy and safety of QHRD106 injection in treating acute ischemic stroke.
CONDITIONS
Official Title
Study to Assess the Efficacy and Safety of QHRD106 Injection in Acute Ischemic Stroke.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Diagnosed with acute ischemic stroke according to current guidelines
- Have not received and do not plan to receive standard intravenous thrombolysis within 24 hours of symptom onset
- First dose of study drug can be given within 24 hours after stroke onset
- NIH Stroke Scale (NIHSS) score between 6 and 20, with limb score sum at least 2
- Modified Rankin Scale (mRS) score of 1 or less before stroke onset
- Signed informed consent by patient or guardian
You will not qualify if you...
- Presence of intracranial hemorrhagic diseases such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, or subarachnoid hemorrhage
- Allergic to study drug, similar components, imaging materials, or products derived from pigs or mammals
- History of severe allergic reactions or allergy to multiple drugs
- Known alpha-1 antitrypsin deficiency
- Severe cognitive impairment with NIHSS consciousness score 2 or higher
- Large anterior circulation infarction exceeding one-third middle cerebral artery territory
- Rapid symptom improvement or symptoms caused by other reasons
- Planning or have undergone endovascular treatment
- Use of neuroprotective drugs after stroke onset
- Severe hypertension despite antihypertensive treatment
- Use of ACE inhibitors within 7 days before screening or planned during trial
- Low blood pressure before randomization after stroke onset
- Active severe infections requiring systemic treatment
- Severe kidney dysfunction or failure
- Severe liver dysfunction or known liver diseases
- Heart failure NYHA grade II or above
- Concurrent cancer or receiving anti-tumor therapy
- Pregnant, breastfeeding, or planning pregnancy
- History of epilepsy or severe mental disorders
- Suspected or confirmed alcohol dependence or recent excessive alcohol use
- Participation in other clinical trials within 3 months
- Severe systemic disease with life expectancy under 90 days
- Unable to tolerate injections or venipuncture
- Considered unsuitable by researchers for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
Y
Yun Xu, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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