Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.
To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.
Genetic: Recombinant Human Plasminogen Activator (HTUPA)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose Finding, Pharmacokinetic and Safety Study of a Recombinant Human Plasminogen Activator (HTU-PA) in Patients With Acute Ischemic Stroke|
- Major neurological improvement measured by NIHSS at 24 hours after treatment. “Major neurological improvement” is defined as 4-point improvement in the NIHSS measurement.
- Major neurological improvement measured by NIHSS at 30 minutes, 60 minutes, 2 hours, 48 hours, 7 days, 30 days, and 90 days after treatment.
|Study Start Date:||April 2001|
|Estimated Study Completion Date:||June 2004|
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.
|Veterans General Hospita-lNeurological Institute|
|No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan, 112|
|Study Chair:||Han-Hwa Hu, M.D.||Taipei Veterans General Hospita-lNeurological Institute|