A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.

Summary

The primary purpose of this trial is to compare the efficacy of different doses of investigator product and comparator product in patients with acute ischemic stroke in 4.5 Hours after stroke onset, and provide a basis of drug administration for phase Ⅲ clinical trial. The secondary purpose of this trial is to compare the safety of different dose of investigational product and comparator product in patients with acute ischemic stroke in 4.5 hours afterstroke onset .

Timeline

Start

2019-07-20

Primary completion

2020-10-31

Completion

2021-03-31

Publications

• Li S, Wang X, Jin A, Liu G, Gu H, Li H, Campbell BCV, Fisher M, Yang Y, Wei Y, Wang J, Wang Y, Zhao X, Liu L, Li Z, Meng X, Wang Y. Safety and Efficacy of Reteplase Versus Alteplase for Acute Ischemic Stroke: A Phase 2 Randomized Controlled Trial. Stroke. 2024 Feb;55(2):366-375. doi: 10.1161/STROKEAHA.123.045193. Epub 2023 Dec 28.

Drugs

Indications