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A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia

NCT02016755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-01-22

Study results available
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Summary

The purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)

Conditions

  • Critical Limb Ischemia
  • Vascular Diseases
  • Peripheral Arterial Disease

Interventions

BIOLOGICAL

HGF Plasmid

Intramuscular injection in the affected limb.

Sponsors & Collaborators

  • AnGes USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Powell, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-03-31
Completion
2018-03-31
FDA Drug
Yes

Countries

  • United States

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 NCT02016755 on ClinicalTrials.gov