At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 240 enrolled
Drug / intervention
TNK-tPAdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Dose-finding Open Study of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) Injection Administered Within 3 Hours After Onset of Hyperacute Ischemic Stroke
In Brief
A Phase 2 clinical trial evaluating TNK-tPA for Acute Ischemic Stroke. Completed, enrolled 240 participants across 24 sites.
Detailed Summary
To explore the safe and efficacious dose of rhTNK-tPA injection administered within 3 hours after onset of hyperacute ischemic stroke; to provide dose evidence for phase III clinical trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke
CountriesChina
CollaboratorsCSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd., The First Hospital Of Qiqihar, Hebei Medical University Third Hospital, Yantai Yuhuangding Hospital, Fudan University, First Affiliated Hospital of Jinan University, The First Hospital of Jilin University, Huashan Hospital, West China Hospital, Inner Mongolia Baogang Hospital, Linyi People's Hospital, The First Affiliated Hospital of Zhengzhou University, Baotou Central Hospital
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
Primary CompletionMay 2020
Study CompletionJul 2020
First PostedDec 2020
TodayJul 2026
First PostedDec 21, 2020
Enrollment StartMay 12, 2018
Primary CompletionMay 30, 2020
Study CompletionJul 10, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.5 years ago
Interventions
TNK-tPAdrug
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol