Safety and Feasibility of the Injectable BL-1040 Implant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by BioLineRx, Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by:
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT00557531
First received: November 12, 2007
Last updated: February 2, 2012
Last verified: February 2012
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BL-1040 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: BioLineRx, Public Company
ClinicalTrials.gov Identifier: NCT00557531     History of Changes
Other Study ID Numbers: 1040.01, 1040.01
Study First Received: November 12, 2007
Last Updated: February 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014