Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure.



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:July 2012
End Date:July 2014
Contact:Joseph Pastore, PhD
Email:jpastore@juventasinc.com
Phone:216-678-9003

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A Phase II Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of JVS-100 Administered by Endomyocardial Injection to Cohorts of Adults With Ischemic Heart Failure


This is a randomized, double-blind, placebo controlled Phase II study is designed to assess
the safety and efficacy of using JVS-100 to treat heart failure.


90 subjects with ischemic cardiomyopathy will be randomized to receive a single dose of 15
or 30 mg of JVS-100 or matching placebo. Subjects will be randomized 1:1:1 to receive either
placebo, 15 mg or 30 mg of JVS-100. Subjects will be monitored overnight for 18-24 hours
post dose and have scheduled visits at 3 days post-injection for safety evaluations. All
subjects will be scheduled for follow-up visits at approximately 30 days (1 month), 120 days
(4 months), and 360 days (12 months) to assess safety and cardiac function.

Inclusion Criteria:

- Willing and able to sign informed consent

- Greater than or equal to 18 years of age

- Subjects with 6 minute hall walk distance ≤ 400 m limited only by cardiac fitness

- Minnesota LWHF questionnaire score ≥20 points

- Ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months

- Residual well-demarcated region of LV systolic dysfunction defined as at least 3
consecutive segments of abnormal wall motion by echocardiography read at the
echocardiography core laboratory

- LVEF ≤40% measured by echocardiography read at the echocardiography core laboratory

- Must meet wall thickness criteria

- Subject has an implanted, functional AICD

- Subjects with diabetes must have had an ophthalmologist exam within the last year
showing no active proliferative retinopathy

- Subject receiving stable optimal pharmacological therapy defined as:

- ACE inhibitor and/or ARB, and Beta-blocker for 90 days with stable dose for 30
days unless contraindicated

- Diuretic in subjects with evidence of fluid retention

- ASA unless contraindicated

- Statin unless contraindicated

- Aldosterone antagonist per physician discretion

Exclusion Criteria:

- Planned revascularization within 30 days following enrollment

- Estimated Glomerular Filtration Rate < 30 ml/min*

- Signs of acute heart failure within 24 hours of scheduled injection

- History of aortic valve regurgitation classified as "moderate" or severe

- Moderate/Severe aortic stenosis defined as AVA <1.5 cm2

Note: Patient should not be excluded if the patient's medical records document that within
the last 6 months the patient has either:

- no aortic stenosis

- mild aortic stenosis

- normal aortic valve

- normal aortic pressure gradient

- aortic pressure gradient < 20 mmHg

- Presence of an artificial aortic valve

- Subjects with aortic aneurysm >3.8 cm

- Mitral regurgitation defined as "severe" measured by echocardiography at the
clinical site.

- Patients with planned mitral valve repair or replacement surgery

- Any patient with a history of cancer will be excluded unless:

- The cancer was limited to curable non-melanoma skin malignancies and/or

- The cancer was removed by a successful tumor resection, with or without radiation or
chemotherapy treatment, 5 years or more prior to enrollment in this study without
recurrence

Subjects must have the following results on age appropriate cancer screenings:

- Subjects age 50 or older have had a Fecal occult blood test (FOBT) or fecal
immunochemical test (FIT) that was negative within the last year

- Women age 30 or older have had a PAP test that was negative within the last 3 years

- Women age 40 or older have had a mammogram that was negative within the last year

- Men above age 45 have had a Prostate-Specific Antigen (PSA) blood test and digital
rectal examination (DRE) that was negative within the last year

- At the request of the site principal investigator, any subject with a non-negative
result thought to be due to a non-cancer-related condition will be evaluated by the
medical monitor for enrollment

Exclusion Criteria (ctd):

- Subjects with persistent or chronic atrial fibrillation will be excluded unless:

- A stable, regular heart rate is maintained with a biventricular pacemaker

- A stable, regular heart rate is maintained with a univentricular pacemaker
pacing less than or equal to 40% of the time

- Subjects with Biventricular pacing device implant within the last 3 months OR
previously implanted Biventricular pacing device with programming planned to be
reoptimized following enrollment in this trial

- Previous solid organ transplant

- Subjects with greater than 40% univentricular RV Pacing

- Subjects with uncontrolled diabetes defined as HbA1c >9.0%

- Inability to complete 6 minute walk or treadmill exercise test

- Participation in an experimental clinical trial within 30 days prior to enrollment

- Any subject who has been enrolled in a gene or stem cell therapy cardiac trial
within the last year

- Life expectancy of less than 1 year

- Positive pregnancy test (serum βHCG) in women of childbearing potential and/or
unwillingness to use contraceptives or limit sexual activity as described in Section
8.2.1 below

- Unwillingness of men capable of fathering a child to agree to use barrier
contraception or limit sexual activity as described in Section 8.2.1 below

- Subjects who are breast feeding

- Subjects with a positive test results for hepatitis B/C and/or HIV

- Total Serum Bilirubin >4.0 mg/dl

- Aspartate aminotransferase (AST) > 120 IU/L

- Alanine aminotransferase (ALT) > 135 IU/L

- Alkaline phosphatase (ALP) >300 IU/L

- Clinically significant elevations in PT or PTT relative to laboratory norms

- Any subject with a known existing LV thrombus or has an LV thrombus detected during
the screening period of this study.

- Subjects with Rutherford class 5 or 6 critical limb ischemia

- Subject with severe chronic obstructive pulmonary disease (COPD)

- Any subject requiring home oxygen use

- Subjects with a history of Systemic Lupus Erythematosus (SLE) flare

- History of drug or alcohol abuse within the last year

- A subject will be excluded if he/she is unfit for the trial based on the discretion
of the site Principal Investigator
We found this trial at
16
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Akron, Ohio 44304
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Birmingham, Alabama 35211
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Dallas, Texas 75226
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Des Moines, Iowa 50314
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Grand Rapids, Michigan 49503
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
215-662-4000
University of Pennsylvania Health System Today at Penn Medicine, someone will make a breakthrough. Someone...
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Saginaw, Michigan 48601
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Tampa, Florida 33613
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Tampa, FL
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