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Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia

NCT01410331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-10-23

No results posted yet for this study

Summary

This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).

Conditions

  • Critical Limb Ischemia

Interventions

BIOLOGICAL

JVS-100(4 mg) or placebo/8 injections

4 mg of JVS-100 or placebo delivered in 8 injections

BIOLOGICAL

JVS-100(8 mg) or placebo/8 injections

8 mg of JVS-100 or placebo delivered in 8 injections

BIOLOGICAL

JVS-100(8 mg) or placebo/16 injections

8 mg of JVS-100 or placebo delivered in 16 injections

BIOLOGICAL

JVS-100(16 mg) or placebo/16 injections

16 mg of JVS-100 or placebo delivered in 16 injections

Sponsors & Collaborators

  • Juventas Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Melina Kibbe, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410331 on ClinicalTrials.gov