Peripheral Arterial Occlusive DiseaseTALISMAN SNCT01135797
Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials
An observational study of Peripheral Arterial Occlusive Disease, run by Sanofi at 7 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- How many people
- 164 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Jun 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients participating in this observational study previously participated in one of the phase I-II studies for the compound
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: Retrospective Safety Survey In Patients Included In Phase I-II 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.
- Conditions
- Peripheral Arterial Occlusive Disease
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients from phase I-II studies | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Deaths
Including all causes of deaths
Measured: 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
Measured: From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135797
- Sponsor's protocol ID
- LTS11315
- Acronym
- TALISMAN S
- Status last verified
- Apr 2011
- First submitted
- 1 Jun 2010
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials
- ClinicalTrials.gov ID
- NCT01135797
- Acronym / sponsor ID
- TALISMAN S / LTS11315
- Conditions
- Peripheral Arterial Occlusive Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from phase I-II studies | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients participating in this observational study previously participated in one of the phase I-II studies for the compound
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Occlusive Disease, run by Sanofi at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Belgium, France, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.