Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials

Peripheral Arterial Occlusive Disease Clinical Trial

— TALISMAN S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135797
• Other study ID #: LTS11315
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: April 27, 2011
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milano
Switzerland	Sanofi-Aventis Administrative Office	Geneva
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Deaths	Including all causes 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	No
Primary	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	From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake	Yes