Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123292
Status:
TERMINATED
Last Update Posted:
2014-04-07
First Post:
2005-07-21
Brief Title:
Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Sponsor:
ThromboGenics
Organization:
ThromboGenics
Study Overview
Official Title:
An Open-label Ascending-dose Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsors decision not to pursue development of uPLi for vascular conditions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion
Detailed Description:
This clinical trial is designed as an open-label dose-escalating single-centre trial of weight-adjusted dose regimens of microplasmin administered intra-arterially as an infusion to patients with acute peripheral arterial occlusion Patients who meet all inclusion criteria and none of the exclusion criteria will be administered study drug for up to 4 hours Different dose regimens will be evaluated in an ascending-dose fashion an infusion will be administered for up to 4 hours
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