To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.
Cerebrovascular disease, the third leading cause of death after heart disease and cancer in developed countries, has an overall prevalence of 794 per 100,000. In the United States, it is estimated that more than 400,000 patients are discharged each year from hospitals after a stroke. The loss of these patients from the work force and the extended hospitalization they require during recovery make serious economic impact. In Taiwan, Cerebrovascular disease is the second cause of death.
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
Injected with study drug; NIHSS administered at 30 minutes, 60 minutes, 2 hours, 24 hours, 48 hours, 7 days, 30 days, and 90 days after treatment.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Major neurological improvement measured by NIHSS at 24 hours after treatment.|
|Secondary||Major neurological improvement measured by NIHSS at 30 minutes, 60 minutes, 2 hours, 48 hours, 7 days, 30 days, and 90 days after treatment.|
|Primary||Major neurological improvement measured by NIHSS at 24 hours after treatment. “Major neurological improvement” is defined as 4-point improvement in the NIHSS measurement.|
- Global Biotech Lead