Peripheral Arterial Occlusive DiseasePhase 1NCT01157156
Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
A Phase 1 study testing XRP0038 (NV1FGF) in people with Peripheral Arterial Occlusive Disease, run by Sanofi at 2 sites in 2 countries.
Trial summary
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- XRP0038 (NV1FGF)
- Type of treatment
- Injection or infusion
- How many people
- 51 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 1999to Sep 2001
- Phase
- Phase 1
- 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
Who may be able to join
- Severe PAOD defined as Rutherford's Grade II, category 4 or Grade III, category 5 and 6
- Pain at rest for at least 2 weeks duration and/or trophic lesions for at least the previous 14 days with no signs of healing (no reduction in ulcer size or depth)
- Objective evidence of peripheral vascular disease (resting Ankle Brachial Index < 0.4 and/or resting Toe Brachial Index < 0.3 and/or metatarsal Peripheral Vascular Resistance flat or barely pulsatile in the diseased limb on 2 consecutive examinations performed at least 2 weeks apart)
- Angiographic demonstration of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries
- Poor candidate for surgical intervention or revascularization procedures (no tibial artery incontinuity as defined from mid-leg distance from the foot and no autologous tissue available)
Who cannot join
- Previous or current history of malignant disease. Patients who had successful tumor resection more than 10 years prior to inclusion into the study and had no recurrence and patients who had curatively resected basal/squamous cancer of the skin were allowed for inclusion
- Abnormal chest X-ray with suspected malignant tumor presence
- Positive stool hemoccult (expect if due to hemorrhoids)
- Positive Prostate Specific Antigen for men with suspected malignant tumor presence
- Abnormal mammography for women with suspected malignant tumor presence
- Papanicolaou smear (for women) of Class IV or Class V characterization
- Proliferative retinopathy
- 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase I, Multi-Center, Open Label, Safety and Tolerability Study of Single and Repeated Administrations of Escalating Dose(s) of NV1FGF Administered by Intra-Muscular Injection in Patients With Severe Peripheral Artery Occlusive Disease
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6).
Secondary objectives are:
- To determine the biological activity of NV1FGF on collateral artery development.
- To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.
Read the detailed description
Screening period of 30 days before dosing. Patients receive a single administration or repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed for a period of 6 months
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- XRP0038 (NV1FGF)
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...)
Measured: 12 weeks
Secondary outcomes (3)
hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography
Measured: 12 weeks
ulcers healing assessment (length, width, type, depth)
Measured: 12 weeks
pain assessment (self-administered visual analog scale)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJun 1999
- Primary completionSep 2001
- Study completionSep 2001
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 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
- NCT01157156
- Sponsor's protocol ID
- TED10106
- Other IDs
- PM101
- Status last verified
- Jul 2010
- First submitted
- 2 Jul 2010
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
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 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Center, Open Label, Safety and Tolerability Study of Single and Repeated Administrations of Escalating Dose(s) of NV1FGF Administered by Intra-Muscular Injection in Patients With Severe Peripheral Artery Occlusive Disease
- ClinicalTrials.gov ID
- NCT01157156
- Acronym / sponsor ID
- TED10106
- Conditions
- Peripheral Arterial Occlusive Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- Primary completion
- Sep 2001 (actual)
- Study completion
- Sep 2001 (actual)
- First posted
- 5 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 evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6).
Secondary objectives are:
- To determine the biological activity of NV1FGF on collateral artery development.
- To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.
Detailed description
Screening period of 30 days before dosing. Patients receive a single administration or repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed for a period of 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe PAOD defined as Rutherford's Grade II, category 4 or Grade III, category 5 and 6
- Pain at rest for at least 2 weeks duration and/or trophic lesions for at least the previous 14 days with no signs of healing (no reduction in ulcer size or depth)
- Objective evidence of peripheral vascular disease (resting Ankle Brachial Index < 0.4 and/or resting Toe Brachial Index < 0.3 and/or metatarsal Peripheral Vascular Resistance flat or barely pulsatile in the diseased limb on 2 consecutive examinations performed at least 2 weeks apart)
- Angiographic demonstration of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries
- Poor candidate for surgical intervention or revascularization procedures (no tibial artery incontinuity as defined from mid-leg distance from the foot and no autologous tissue available)
Key exclusion criteria (8 listed)
- Previous or current history of malignant disease. Patients who had successful tumor resection more than 10 years prior to inclusion into the study and had no recurrence and patients who had curatively resected basal/squamous cancer of the skin were allowed for inclusion
- Abnormal chest X-ray with suspected malignant tumor presence
- Positive stool hemoccult (expect if due to hemorrhoids)
- Positive Prostate Specific Antigen for men with suspected malignant tumor presence
- Abnormal mammography for women with suspected malignant tumor presence
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 | – |
Primary outcome
Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...)
Time frame: 12 weeks
3 secondary outcomes
hemodynamic parameters (TcPO2, Ankle Brachial Index, Toe Brachial Index, pulse volume recording) and angiography
Time frame: 12 weeks
ulcers healing assessment (length, width, type, depth)
Time frame: 12 weeks
pain assessment (self-administered visual analog scale)
Time frame: 12 weeks
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 5 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XRP0038 (NV1FGF) in people with Peripheral Arterial Occlusive Disease, run by Sanofi at 2 sites in 2 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 5 inclusion and 8 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 5 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 2 sites in United States, Finland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (time frame: 12 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 NCT01157156, 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 5 Jul 2010.