NCT01643590

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Juventas Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ischemic Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	JVS-100 15 mg dose Injection	Intramyocardial Injection
BIOLOGICAL	Placebo Injection	Intramyocardial Injection
BIOLOGICAL	JVS-100 30 mg dose injection	Intramyocardial Injection

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2012-07-18
• Last updated: 2014-02-07

Locations

16 sites across 1 country: United States