Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00418275|
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : January 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident||Genetic: Recombinant Human Plasminogen Activator (HTUPA)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Finding, Pharmacokinetic and Safety Study of a Recombinant Human Plasminogen Activator (HTU-PA) in Patients With Acute Ischemic Stroke|
|Study Start Date :||April 2001|
|Study Completion Date :||June 2004|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418275
|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|