Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials (TALISMAN S)

Sanofi

Status: Completed

Conditions: Peripheral Arterial Occlusive Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01135797

LTS11315

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

164 participants in 1 patient group

Patients from phase I-II studies