Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials

Sanofi164 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

164

Conditions

Peripheral Arterial Occlusive Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patient randomized, treated and alive at the end of the phase I-II study participation, irrespective of their treatment group, * Who signed the TALISMAN survey informed consent (or for deceased patients, the informed consent was signed the legal representative/family member as per national regulations - except in countries where Ethics Committee approval only is required for retrospective data collection). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (7)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Diegem, Belgium

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Berlin, Germany

Outcomes

Primary Outcomes

Incidence of Deaths

Including all causes 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

Incidence of safety events of interest

Safety events of interest when gene therapy is used i.e. development of any new/recurrent cancer, immunogenicity reactions

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

Data from ClinicalTrials.gov

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