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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00243308
Other study ID # Serp-1-01-002
Secondary ID
Status Terminated
Phase Phase 2
First received October 19, 2005
Last updated February 5, 2009
Start date October 2005
Est. completion date December 2008

Study information

Verified date February 2009
Source Viron Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 0.05 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.


Description:

A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% 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 later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.


Recruitment information / eligibility

Status Terminated
Enrollment 72
Est. completion date December 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission

- Scheduled for PCI

Exclusion Criteria:

- CABG within 6 months

- Acute ST elevation, eligible for thrombolysis on initial examination

- Coronary lesions with total thrombotic occlusions

- Current immunosuppressant therapy

Study Design


Intervention

Drug:
Serine proteinase-1 (Serp-1)


Locations

Country Name City State
Canada Foothills Medical Center Calgary Ontario
Canada London Health Sciences Centre London Ontario
Canada Montreal Heart Institute Montreal Quebec
Canada University of Ottawa Heart Institute Ottawa Ontario
Canada Victoria Heart Institute Vicotria British Columbia
United States University of Florida Gainesville Florida
United States Spectrum Health Grand Rapids Michigan
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Viron Therapeutics Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety (Adverse events collected until 6 months post-dose)
Secondary Inflammatory marker analysis
Secondary MACE
Secondary Restenosis at 6 months
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