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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cardiology PC
Birmingham, Alabama, United States
University of Florida
Gainesville, Florida, United States
Pepin Heart Institute
Tampa, Florida, United States
Iowa Heart Center
Des Moines, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Spectrum Health
Grand Rapids, Michigan, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Start Date
July 1, 2012
Primary Completion Date
October 1, 2014
Completion Date
November 1, 2014
Last Updated
February 7, 2014
90
ESTIMATED participants
JVS-100 15 mg dose Injection
BIOLOGICAL
Placebo Injection
BIOLOGICAL
JVS-100 30 mg dose injection
BIOLOGICAL
Lead Sponsor
Juventas Therapeutics, Inc.
NCT07347197
NCT03491969
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01709279