Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials

Completed

• Conditions: Peripheral Arterial Occlusive Disease

• Registration Number: NCT01135797
• Lead Sponsor: Sanofi

Brief Summary

The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Deaths	From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake	Including all causes of deaths
Incidence of safety events of interest	From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake	Safety events of interest when gene therapy is used i.e. development of any new/recurrent cancer, immunogenicity reactions

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford Surrey, United Kingdom