NCT00557531

Safety and Feasibility of the Injectable BL-1040 Implant

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: BioLineRx, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, multi-center, open label study designed to assess the safety and feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial tissue.

Detailed description

ENDPOINTS Preliminary safety endpoints Occurrence of all adverse events including but not limited to All MIs Cardiovascular hospitalization Serious ventricular arrhythmias sustained: VT (symptomatic or sustained VT \[duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse\]) VF symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block Symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) Renal failure Stroke Death Secondary safety endpoints Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DEVICE	BL-1040	2 mL of BL-1040

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-01-01
• Completion: 2014-01-01
• First posted: 2007-11-14
• Last updated: 2012-02-03

Locations

1 site across 1 country: Germany