Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 11:28 AM
Study NCT ID:
NCT00123292
Status:
TERMINATED
Last Update Posted:
2014-04-07
First Post:
2005-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Sponsor:
ThromboGenics
Organization:
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?:
Sponsor's 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:
True
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?: