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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

164

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

June 1, 2010

Completed

Same day until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

June 1, 2010

Last Update Submit

April 27, 2011

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (2)

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
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

Study Arms (1)

Patients from phase I-II studies

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients participating in this observational study previously participated in one of the phase I-II studies for the compound

You may qualify if:

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.

Contact the study team to confirm eligibility.