Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke
- Summary
- This study is designed to determine the safety and efficacy of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects.
- Short title
- Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-12-16
- First posted
- 2024-01-11
- Registry last updated
- 2025-10-28
- Primary completion date
- 2024-11-26
- Start date
- 2023-12-29
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- 1:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06202378
- ClinicalTrials.gov ID
- NCT06202378
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
Timeframe: 90±7 days
Proportion of participants with mRS scores of 0-1 at Day 90
Shift analysis/ Ordinal analysis
Timeframe: 90±7 days
A shift of one or more categories to reduced functional dependence analyzed across the whole distribution of outcomes on the mRS at Day 90
Modified Rankin Scale (mRS), with scores of 0-1 at Day 30
Timeframe: 30±3 days
Proportion of participants with mRS Scores of 0-1 at Day 30
Modified Rankin Scale (mRS), with scores of 0-2 at Day 30
Timeframe: 30±3 days
Proportion of participants with mRS Scores of 0-2 at Day 30
Modified Rankin Scale (mRS), with scores of 0-2 at Day 90
Timeframe: 90±7 days
Proportion of participants with mRS Scores of 0-2 at Day 90
National Institute of Health stroke scale (NIHSS) on day 7or 8
Timeframe: 7 days or 8 days
The proportion of participants with NIHSS scores of 0-1 or with ≥4 point reduction from baseline on day 7 or 8 (after the completion of the final dose)
National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge
Timeframe: 14±2 days
The proportion of participants with NIHSS scores of 0 to 1 or with 4 points reduction from baseline on day 14 or at discharge
Barthel index (BI) at Day 30
Timeframe: 30±3 days
Proportion of participants with Barthel index ≥95 at Day 30
Barthel inde (BI) at Day 90
Timeframe: 90±7 days
Proportion of participants with BI ≥95 at Day 90
National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge
Timeframe: 14±2 days or at discharge
Changes in NIHSS scores from baseline at Day 14 or at discharge
Symptomatic intracranial hemorrhage
Timeframe: 22-36h after thrombolysis
Symptomatic intracranial hemorrhage within 36h after thrombolysis (Safe Implementation of Thrombolysis in Stroke-Monitoring Study Criteria)
Mortality
Timeframe: 90±7 days
Mortality over the 90-day study period
Serious adverse events
Timeframe: 90±7 days
Serious adverse events over the 90-day study period
Adverse events
Timeframe: 90±7 days
Adverse events over the 90-day study period
Changes in laboratory test indicators
Timeframe: 7 days or 8 days，14±2 days，90±7 days
Changes in laboratory test indicators on day 7 or 8(at the end of the last dose), at Day 14 or at discharge, and at Day 90
Changes in vital signs before and after administration
Timeframe: 7 days or 8 days，14±2 days，90±7 days
Changes in vital signs on day 7 or 8 (at the end of the last dose), at Day14 or at discharge , and at Day 90
12-lead electrocardiogram
Timeframe: 90±7 days
Abnormal 12-lead electrocardiogram over the 90-day study period
Vital signs
Timeframe: 90±7 days
Abnormal vital signs over the 90-day study period
Physical examination
Timeframe: 90±7 days
Abnormal results of physical examination over the 90-day study period
Laboratory test indicators
Timeframe: 90±7 days
Abnormal laboratory test indicators over the 90-day study period
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
- Age 18-80 years old (including upper and lower limits);
- Clinically diagnosed as acute ischemic stroke according to the latest guidelines;
- Patients with acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this research center) within 8h after the onset of the disease;
- Participants who have NIHSS ≥5 and ≤ 22 before thrombolysis;
- Pre-stroke mRS Score ≤1;
- Participants or legally authorized representatives who are able and willing to sign informed consent.
- Complicated with intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
- Severe disturbance of consciousness: patients with NIHSS 1a consciousness level item score ≥2;
- Cerebral Computed tomography (CT) or Magnetic resonance imaging (MRI) indicated a large anterior circulation cerebral infarction (ASPECT score < 6 or infarct area greater than 1/3 of the middle cerebral artery blood supply area);
- Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acute ischemic symptoms suspected to be caused by other causes;
- Patients who are ready to receive or have receive intravascular therapy;
- After the onset of the disease, drugs with neuroprotective effects have been applied in the instructions. Such as commercially available Edaravone, Edaravone and Dexborneol Concentrated Solution for Injection, Butylphthalide, Nimodipine, Ganglioside, Citicoline, Piracetam, Oxiracetam, Human Urinary Kallidinogenase, Cinepazide, Mouse Nerve Growth Factor For Injection, Cerebrolysin, Deproteinised Calf Blood Serum Injection, Deproteinised Calf Blood Extractives Injection, etc.;
- Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after taking antihypertensive drugs before thrombolysis;
- Severe renal insufficiency: serum creatinine >2 times the upper limit of normal or creatinine clearance (CLcr)< 30mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency; (Note: Cockcroft-Gault formula: ① Male: CLcr (mL/min) = [140 - age (yrs)]× body weight (kg) / [0.814 × serum creatinine (μmol/L)]; (2) female: CLcr (mL/min) = {[140 - age (years old)] by weight (kg) / [0.814 x serum creatinine (μmol/L)]} x 0.85)
- Severe liver function impairment: Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST)>3 times the upper limit of normal, or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.;
- Patients with a heart function rating above Class II (according to the New York Heart Association (NYHA) heart function rating) or a history of congestive heart failure;
- Patients with concurrent malignant tumors or undergoing anti-tumor therapy;
- Allergic to experimental drugs or similar ingredients or materials used in imaging examinations;
- Patients during pregnancy, breastfeeding or planning pregnancy;
- Patients who have a history of epilepsy or have had seizure-like symptoms at the onset of stroke, or suffer from serious mental disorders, intellectual disabilities or dementia;
- Suspected or confirmed alcohol dependence, or drinking more than 3 units (male) or 2 units (female) of alcohol within 24 hours prior to onset (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
- Patients have participated in or are participating in another clinical study within the 3 months before singing informed consent;
- Patients who are judged unsuitable for participation by the investigators in the study.
- Beijing Tiantan Hosptial，Capital Medical UniversityBeijing, China
- Yuebei People's HospitalShaoguan, China
- Hengshui People's HospitalHengshui, China
- Tangshan Workers' HospitalTangshan, China
- Nanshi Hospital of NanyangNanyang, China
- General Hospital of Pingmei Shenma GroupPingdingshan, China
- Keshiketeng Banner Traditional Chinese Medicine and Mongolian Medicine HospitalChifeng, China
- The First Hospital of Jilin UniversityChangchun, China
- Beipiao Central HospitalBeipiao, China
- Shenyang Medical College Affiliated Central HospitalShenyang, China
- The First People's Hospital of ShenyangShenyang, China
- Linyi People's HospitalLinyi, China
- The First People's Hospital of TanchengLinyi, China
- Sinopharm Tongmei General HospitalDatong, China
- Linfen Central HospitalLinfen, China
- Linfen People's HospitalLinfen, China
Related records
Drugs (1)
Collaborators (1)
- Beijing Tiantan Hospital
Lead sponsors (1)
Conditions (2)
- Ischemic stroke
- Transient ischemic attack Primary condition