Severe Peripheral Artery Occlusive DiseasePhase 2TALISMAN202NCT00798005
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
A Phase 2 study testing XRP0038 (NV1FGF) in people with Severe Peripheral Artery Occlusive Disease, run by Sanofi at 1 site in United States.
Trial summary
Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Severe Peripheral Artery Occlusive Disease
- What is being tested?
- XRP0038 (NV1FGF)
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jul 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent was to be signed before proceeding with any study procedure.
- Patients with severe PAD.
- Trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (Day 1).
- Patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart.
- Demonstration or documentation of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography (MRA)
- Transcutaneous oxygen pressure (TcPO2): mean resting supine TcPO2 of the foot of ≤40 mmHg based on 2 separate measures performed at least 1 week apart
- Poor/not candidates for revascularization
Who cannot join
- Previous or current history of malignant disease.
- Positive cancer screening (liver, prostate, colon, cervix, breast, lung)
- Successful lower extremity surgery (bypass/angioplasty of the leg to be treated) within 3 months prior to the first administration of study treatment [Day 1]).
- Patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment.
- Patients with a history of severe renal failure.
- Creatinine >2.0 mg/dL (176 µmol/L) or estimated creatinine clearance <30 mL.
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- Serious concomitant medical conditions not adequately controlled (other than severe PAD),
- Buerger's disease.
- Patients in dialysis.
- Active proliferative retinopathy
- Patients 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.
- Positive serology for HIV 1 or 2.
- Participation in clinical trials of non-approved experimental agents within 4 weeks before study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Different Doses and Schedules of Administration of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers.
Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD
- Being tested
- XRP0038 (NV1FGF)
- Keywords
- NV1FGF, PAOD, CLI
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.
Secondary outcomes (1)
evaluate the biodistribution of NV1FGF and to measure serum levels of antibodies against FGF-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJun 2002
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Peripheral Artery 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
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798005
- Sponsor's protocol ID
- DRI6144
- Other IDs
- NV1FGF-PM202
- Acronym
- TALISMAN202
- Status last verified
- Jun 2017
- First submitted
- 24 Nov 2008
- Last updated
- 8 Jun 2017
- Results posted
- No
Publications
Henry TD, Mendelsohn F, Comerota A, Pham E, Grek V, Coleman M, Meyer F, Annex B Dose and regimen effects of intramuscular NV1FGF in patients with critical limb ischemia: A randomized, double-blind, placebo controlled study. Eur H J 2006, 27 Suppl 1 Abs P1497
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 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Different Doses and Schedules of Administration of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
- ClinicalTrials.gov ID
- NCT00798005
- Acronym / sponsor ID
- TALISMAN202 / DRI6144
- Keywords
- NV1FGF, PAOD, CLI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 25 Nov 2008 (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.
Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers.
Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent was to be signed before proceeding with any study procedure.
- Patients with severe PAD.
- Trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (Day 1).
- Patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart.
- Demonstration or documentation of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography (MRA)
Key exclusion criteria (14 listed)
- Previous or current history of malignant disease.
- Positive cancer screening (liver, prostate, colon, cervix, breast, lung)
- Successful lower extremity surgery (bypass/angioplasty of the leg to be treated) within 3 months prior to the first administration of study treatment [Day 1]).
- Patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment.
- Patients with a history of severe renal failure.
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) | Drug | – |
Primary outcome
evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.
1 secondary outcome
evaluate the biodistribution of NV1FGF and to measure serum levels of antibodies against FGF-1
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 8 Jun 2017.
- Results publicationHenry TD, Mendelsohn F, Comerota A, Pham E, Grek V, Coleman M, Meyer F, Annex B Dose and regimen effects of intramuscular NV1FGF in patients with critical limb ischemia: A randomized, double-blind, placebo controlled study. Eur H J 2006, 27 Suppl 1 Abs P1497
- 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.
- Related InfoLink provided by the sponsor.
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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.
ICD CSD study director
Sanofi
1 site in 1 country: 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 Severe Peripheral Artery Occlusive Disease, run by Sanofi at 1 site in United States.
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 7 inclusion and 14 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.. 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 NCT00798005, which also lists 2 linked publications.
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 8 Jun 2017.