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Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation

NCT01157143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2010-07-05

No results posted yet for this study

Summary

The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.

Secondary objectives :

* To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF
* To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site)
* To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site)
* To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma
* To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site
* To collect data from plasma NV1FGF pharmacokinetics
* To evaluate healing of the amputation site

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

DRUG

XRP0038 (NV1FGF)

Pharmaceutical form : solution Route of administration : intramuscular

Sponsors & Collaborators

Principal Investigators

  • International Clinical Development Clinical Study Director · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2003-10-31
Completion
2003-10-31

Countries

  • United States
  • Switzerland

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 NCT01157143 on ClinicalTrials.gov