Peripheral Arterial Occlusive DiseasePhase 2TALISMAN 211NCT01157871
Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
A Phase 2 study testing XRP0038 (NV1FGF) in people with Peripheral Arterial Occlusive Disease, run by Sanofi at 4 sites in 4 countries.
Trial summary
The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo. The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- XRP0038 (NV1FGF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jun 2004to Aug 2005
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>40 years
- History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
- Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
- Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
Who cannot join
- Evidence of other causes for leg pain other than intermittent claudication.
- Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…)
- Pain at rest
- Buerger's disease
- Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
- Subjects with serum creatinine > 2 mg/dl (176 µmol/l) and subjects on dialysis.
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- Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
- Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
- Previous treatment with any angiogenic growth factor
- Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
- Serious concomitant medical conditions not adequately controlled.
- Current alcohol or drug abuse
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication
The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.
The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.
Read the detailed description
Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- XRP0038 (NV1FGF), placebo
- 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.
XRP0038 (NV1FGF)Drug
Pharmaceutical form:solution
Route of administration: intramuscular
placeboDrug
Pharmaceutical form:solution
Route of administration: intramuscular
| Study group | Role | What they receive |
|---|---|---|
| placebo | Experimental | 4 administrations at 2-week interval of placebo solution Receives: Drug: placebo |
| NV1FGF 16 mg | Experimental | 4 administrations at 2-week interval of 4mg at each administration Receives: Drug: XRP0038 (NV1FGF) |
| NV1FGF 32 mg | Experimental | 4 administrations at 2-week interval of 8mg at each administration Receives: Drug: XRP0038 (NV1FGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13
Measured: 13 weeks
Secondary outcomes (4)
NV1FGF DNA 69 base pair (bp) in plasma
Measured: up to week 27
NV1FGF DNA 825 bp in plasma
Measured: up to week 27
FGF-1 in plasma
Measured: up to week 27
Anti-FGF1 antibodies in serum
Measured: up to week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJun 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- International Clinical Development Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157871
- Sponsor's protocol ID
- ACT6141
- Other IDs
- PM211
- Acronym
- TALISMAN 211
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Niebuhr A, Henry T, Goldman J, Baumgartner I, van Belle E, Gerss J, Hirsch AT, Nikol S. Long-term safety of intramuscular gene transfer of non-viral FGF1 for peripheral artery disease. Gene Ther. 2012 Mar;19(3):264-70. doi: 10.1038/gt.2011.85. Epub 2011 Jun 30.
PubMed 21716303
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT01157871
- Acronym / sponsor ID
- TALISMAN 211 / ACT6141
- Conditions
- Peripheral Arterial Occlusive Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 7 Jul 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 primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.
The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.
Detailed description
Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Experimental | Drug: placebo4 administrations at 2-week interval of placebo solution |
| NV1FGF 16 mg | Experimental | Drug: XRP0038 (NV1FGF)4 administrations at 2-week interval of 4mg at each administration |
| NV1FGF 32 mg | Experimental | Drug: XRP0038 (NV1FGF)4 administrations at 2-week interval of 8mg at each administration |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>40 years
- History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
- Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
- Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
Key exclusion criteria (13 listed)
- Evidence of other causes for leg pain other than intermittent claudication.
- Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…)
- Pain at rest
- Buerger's disease
- Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XRP0038 (NV1FGF)Pharmaceutical form:solution Route of administration: intramuscular | Drug | NV1FGF 16 mg, NV1FGF 32 mg |
| placeboPharmaceutical form:solution Route of administration: intramuscular | Drug | placebo |
Primary outcome
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13
Time frame: 13 weeks
4 secondary outcomes
NV1FGF DNA 69 base pair (bp) in plasma
Time frame: up to week 27
NV1FGF DNA 825 bp in plasma
Time frame: up to week 27
FGF-1 in plasma
Time frame: up to week 27
Anti-FGF1 antibodies in serum
Time frame: up to week 27
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 7 Jul 2010.
- Derived from this study: PubMed 21716303Niebuhr A, Henry T, Goldman J, Baumgartner I, van Belle E, Gerss J, Hirsch AT, Nikol S. Long-term safety of intramuscular gene transfer of non-viral FGF1 for peripheral artery disease. Gene Ther. 2012 Mar;19(3):264-70. doi: 10.1038/gt.2011.85. Epub 2011 Jun 30.
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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.
International Clinical Development Study Director study director
Sanofi
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XRP0038 (NV1FGF) in people with Peripheral Arterial Occlusive Disease, run by Sanofi at 4 sites in 4 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 4 inclusion and 13 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 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium, Germany, Switzerland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157871, which also lists 1 linked publication.
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 7 Jul 2010.