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Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia

NCT02144610 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-08-13

Study results available
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Summary

Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.

Conditions

  • Critical Limb Ischemia

Interventions

BIOLOGICAL

HGF Plasmid (AMG0001)

IM

BIOLOGICAL

Matching Placebo

IM

Sponsors & Collaborators

  • AnGes USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard J. Powell, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-12
Primary Completion
2016-11-28
Completion
2016-11-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Sweden

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 NCT02144610 on ClinicalTrials.gov