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Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease

NCT00368797 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2008-11-18

No results posted yet for this study

Summary

This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was assessed by the complete healing of at least one ulcer in the treated limb, 25 week post-baseline and secondary by the rate of amputation and death.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

XRP0038 (NV1FGF)

Sponsors & Collaborators

Principal Investigators

  • Sigrid NIKOL, Prof. · Universitätsklinikum Münster

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2005-04-30
Completion
2005-04-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Switzerland
  • 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 NCT00368797 on ClinicalTrials.gov