Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123305
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2005-07-21
Brief Title:
Intravenous Administration of Microplasmin for Treatment of Acute Ischemic Stroke
Sponsor:
ThromboGenics
Organization:
ThromboGenics
Study Overview
Official Title:
A Multicentre Double-Blind Placebo-Controlled Ascending-dose Clinical Trial of Intravenous Microplasmin Administration in Patients With Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to patients who have suffered an acute stroke within 12 hours before randomization
Detailed Description:
While the primary objective of the trial is safety evaluation efficacy assessments will also be obtained including MRIMRA including DWI PWI and T2 imaging and plasma surrogate biomarkers Clinical outcome will also be assessed at 7days 30 days and 90 days post-treatment At each of these visits mortality and neurological assessments NIHSS Barthel index mRankin scale will be performed In addition vital status will be assessed vial a telephone contact at 60 days post-treatment
The trial will investigate three dose regimens of microplasmin all of which are within the range of doses previously evaluated in a Phase I trial in healthy volunteers the planned sample size for the trial is approximately 40 patients
The study will consist of 3 phases - the Baseline In-hospital Phase and Follow up Phase Baseline is from study entry through randomisation the In-hospital phase is from treatment with study drug through hospital discharge or day 7 whichever occurs first The follow up phase consists of visits to the hospital 30 days 3 days from the day of study drug administration Hospital discharge is defined as the end of the discharge from the acute hospital setting Discharge may be to home to a rehabilitation setting or to a non-acute hospital setting
The trial will investigate three dose regimens of microplasmin all of which are within the range of doses previously evaluated in a Phase I trial in healthy volunteers the planned sample size for the trial is approximately 40 patients
The study will consist of 3 phases - the Baseline In-hospital Phase and Follow up Phase Baseline is from study entry through randomisation the In-hospital phase is from treatment with study drug through hospital discharge or day 7 whichever occurs first The follow up phase consists of visits to the hospital 30 days 3 days from the day of study drug administration Hospital discharge is defined as the end of the discharge from the acute hospital setting Discharge may be to home to a rehabilitation setting or to a non-acute hospital setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None