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

Recruiting Phase 3 Interventional Study
Acute Ischemic Stroke
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
890 (estimated)
Sponsor
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. · Industry
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About This Trial
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 wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Aged ≥ 18 years, regardless of gender; 2. Time from symptom onset to treatment is 4.5 - 24 hours(Including the boundary values.), including patients with wake-up stroke or stroke without witnesses; the time of symptom onset is defined as the "last known normal time"; 3. Modif…
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Clinical Trials Information Group officer

031169085587

ctr-contact@cspc.cn

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