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Growth Factor

NV1FGF 16 mg for Peripheral Artery Disease (TALISMAN 211 Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo. The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.

Eligible Conditions
  • Peripheral Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Group I: placeboExperimental Treatment1 Intervention
4 administrations at 2-week interval of placebo solution
Group II: NV1FGF 32 mgExperimental Treatment1 Intervention
4 administrations at 2-week interval of 8mg at each administration
Group III: NV1FGF 16 mgExperimental Treatment1 Intervention
4 administrations at 2-week interval of 4mg at each administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Riferminogene pecaplasmid
Not yet FDA approved
placebo
2010
Completed Phase 4
~6580

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,204 Previous Clinical Trials
4,036,742 Total Patients Enrolled
International Clinical Development Study DirectorStudy DirectorSanofi
8 Previous Clinical Trials
477 Total Patients Enrolled
~2 spots leftby Nov 2025
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