Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.

Completed

Phase 1/2 Results

Trial Description

To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.

Detailed Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

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.

Outcomes

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.

Sponsors