Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

890

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Acute Ischemic Stroke
Interventions
DRUG

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.

DRUG

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.

All Listed Sponsors
lead

CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

INDUSTRY