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Clinical Trials/NCT01135797
NCT01135797
Completed
N/A

Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials

Sanofi1 site in 1 country164 target enrollmentJune 2010
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ConditionsPeripheral Arterial Occlusive Disease

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripheral Arterial Occlusive Disease
Sponsor
Sanofi
Enrollment
164
Locations
1
Primary Endpoint
Incidence of Deaths
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
December 2010
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sanofi

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of Deaths

Time Frame: 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

Time Frame: 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

Study Sites (1)

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