Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243308
Status:
TERMINATED
Last Update Posted:
2009-02-06
First Post:
2005-10-19
Brief Title:
Serp-1 for the Treatment of Acute Coronary Syndrome
Sponsor:
Viron Therapeutics Inc
Organization:
Viron Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Multicentre Double-Blind Placebo-Controlled Dose Escalating Trial of the Safety Pharmacokinetics and Biological Activity of 3 Consecutive Daily Doses of Serp-1 When Added to Conventional Therapy in Patients With Acute Coronary Syndromes Non ST-Elevation Myocardial Infarction andor Unstable Angina
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Third dose group not recruited due to slow enrollment
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Males and females aged 18-80 years who present with ACS unstable angina and non ST-elevation MI defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 005 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR angina and per confirmatory angiogram has been scheduled for percutaneous coronary angioplasty The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome ACS requiring early intervention
Detailed Description:
A total of 72 subjects will be enrolled separated into 3 dose groups and centrally randomized in a 31 ratio of Serp-1 injection to placebo controlSubjects will receive Serp-1 by intravenous IV bolus injection daily for 3 days at dose levels of 50 15 and 50 ugkgdose or placebo 09 normal saline added to any prescribed therapy for ACS Serp-1 will be administered as a single IV bolus injection The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours laterSubjects will be evaluated for adverse events serum inflammatory markers and restenosis rates at 6 months post-dose
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