Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418483
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2007-01-02
Brief Title:
A Dose Escalation and Safety Study of Plasmin Human In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
Sponsor:
Grifols Therapeutics LLC
Organization:
Grifols Therapeutics LLC
Study Overview
Official Title:
A Sequential Phase III Dose Escalation and Dose Selection Safety Study of Regional Intra-thrombus Plasmin Human Infusion In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
Status:
COMPLETED
Status Verified Date:
2016-10
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:
PRIORITY
Brief Summary:
The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin Human in acute peripheral arterial occlusion aPAO The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography
Detailed Description:
There is an unmet need for proven thrombolytic agent in acute peripheral arterial occlusion aPAO The current assortment of plasminogen activators are slow to dissolve clots in the leg and may lead to bleeding complications Plasmin is a direct thrombolytic that may act more quickly when infused directly into the clot and thus assist in restoring blood flow to the leg There is a large reserve in blood alpha-2 antiplasmin in the blood to rapidly inactivate Plasmin outside of the clot Plasmin has the potential for an improved bleeding risk profile in aPAO
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