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Safety and Feasibility of the Injectable BL-1040 Implant

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ClinicalTrials.gov Identifier: NCT00557531
Recruitment Status : Unknown
Verified February 2012 by BioLineRx, Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2007
Last Update Posted : February 3, 2012
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by:
BioLineRx, Ltd.

Tracking Information
First Submitted Date  ICMJE November 12, 2007
First Posted Date  ICMJE November 14, 2007
Last Update Posted Date February 3, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00557531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of the Injectable BL-1040 Implant
Official Title  ICMJE Safety and Feasibility of the Injectable BL-1040 Implant
Brief 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE Device: BL-1040
2 mL of BL-1040
Study Arms  ICMJE Experimental: BL-1040
Intervention: Device: BL-1040
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2007)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00557531
Other Study ID Numbers  ICMJE 1040.01
1040.01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioLineRx, Public Company
Study Sponsor  ICMJE BioLineRx, Ltd.
Collaborators  ICMJE Sheba Medical Center
Investigators  ICMJE
Principal Investigator: Paul Vermeersch, MD Antwerp MC
PRS Account BioLineRx, Ltd.
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP