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Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions

NCT00566657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2016-05-02

No results posted yet for this study

Summary

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

Secondary objectives are to evaluate:

* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
* The safety of riferminogene pecaplasmid in the study population.

Conditions

  • Peripheral Vascular Diseases

Interventions

BIOLOGICAL

riferminogene pecaplasmid

Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated

BIOLOGICAL

Placebo (for riferminogene pecaplasmid)

Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-08-31
Completion
2012-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Poland
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT00566657 on ClinicalTrials.gov