Safety and Feasibility of the Injectable BL-1040 Implant - Full Text View

Sponsor:	BioLineRx, Ltd.
Collaborator:	Sheba Medical Center
Information provided by:	BioLineRx, Ltd.
ClinicalTrials.gov Identifier:	NCT00557531

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Disease	Device: BL-1040	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Safety and Feasibility of the Injectable BL-1040 Implant

Further study details as provided by BioLineRx, Ltd.:

Primary Outcome Measures:

Occurrence of all AEs including but not limited to All MIs CV hospitalization Serious ventricular arrhythmias sustained: Symptomatic heart failure Renal failure Stroke Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BL-1040: Experimental	Device: BL-1040 2 mL of BL-1040

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent
18 to 75 years of age, inclusive
Male or female
Negative pregnancy test for women of child-bearing potential, or surgically sterile, or post menopausal
Acute MI defined as:
- Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
  - Ischemic symptoms;
  - Development of pathologic Qwaves on the ECG;
  - ECG changes indicative of ischemia (ST segment elevation or depression)
  - First anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads])
  - Regional wall motion score index (at least 4 out of 16 akinetic segments)
One or more of the following:
- LVEF >20% and <45% measured and calculated by 2-dimensional measurement
- Biomarkers: peak CK > 2000 IU
- Infarct size > 25% as measured by MRI
- Successful revascularization with PCI with 1 stent only, within 7 days of the index MI
- At time of application of study device, patient must have patent infarct related artery (IRA) and TIMI flow grade = 3

Exclusion Criteria:

History of CHF, Class I to Class IV, as per NYHA criteria
History of prior LV dysfunction
At time of application of study device - Killip III-IV (pulmonary edema, cardiogenic shock - hypotension systolic < 90 mmHg and evidence of peripheral hypoperfusion oliguria, cyanosis, sweating) or HR > 100 bpm
Prior CABG
Prior MI
History of stroke
Significant valvular disease (moderate or severe)
Patient is a candidate for CABG or PCI on non-IRA
Patient is being considered for CRT within the next 30 days
Renal insufficiency (eGFR < 60)
Chronic liver disease (> 3 times upper limit of normal)
Life expectancy < 12 months
Current participant in another clinical trial, or participation in another trial within the last 6 months
Any contraindication to coronary angiography, MRI or PCI procedures
Patient taking anti-coagulation medication prior to MI
Pregnant or lactating women; pregnancy confirmed by urine pregnancy test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557531

Locations

Germany
Heidelberg University MC
Heidelberg, Germany

Sponsors and Collaborators

BioLineRx, Ltd.

Sheba Medical Center

Investigators

Principal Investigator:

Paul Vermeersch, MD

Antwerp MC

More Information

No publications provided

Responsible Party:	Public Company ( BioLineRx )
Study ID Numbers:	1040.01, 1040.01
Study First Received:	November 12, 2007
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00557531 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2009