Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: TALISMAN S

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 3, 2010
Registry last updated: Apr 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed