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Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
Sponsor: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study plans to enroll patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset (including wake-up strokes and strokes without witnesses). A centralized 1:1 randomization will be adopted, and eligible participants will be randomly assigned to two groups: the experimental group will receive rhTNK-tPA at a dose of 0.25 mg/kg, while the placebo group will receive rhTNK-tPA placebo.
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection (rhTNK-tPA, Mingfule) in Intravenous Thrombolysis for Acute Ischemic Stroke With Extended Time Window (4.5-24 Hours After Onset).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
890
Start Date
2025-11-30
Completion Date
2027-09-30
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
rhTNK-tPA
Each vial should be dissolved in 3mL of sterile water for injection to prepare a drug solution with a concentration of 5.33mg/mL. Calculate the total drug amount based on the participant's actual body weight, measure the required volume of the drug solution, and ensure the maximum dose does not exceed 25mg. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.
Placebo
One vial is dissolved in 3mL of sterile water for injection. Calculate the total drug amount based on the participant's actual body weight, then measure the required volume of the drug solution. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.
Locations (1)
Puyang Oilfield General Hospital
Puyang, Henan, China