Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
NCT ID: NCT01157871
Last Updated: 2010-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2004-06-30
2005-08-31
Brief Summary
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The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo
4 administrations at 2-week interval of placebo solution
placebo
Pharmaceutical form:solution
Route of administration: intramuscular
NV1FGF 16 mg
4 administrations at 2-week interval of 4mg at each administration
XRP0038 (NV1FGF)
Pharmaceutical form:solution
Route of administration: intramuscular
NV1FGF 32 mg
4 administrations at 2-week interval of 8mg at each administration
XRP0038 (NV1FGF)
Pharmaceutical form:solution
Route of administration: intramuscular
Interventions
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XRP0038 (NV1FGF)
Pharmaceutical form:solution
Route of administration: intramuscular
placebo
Pharmaceutical form:solution
Route of administration: intramuscular
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
40 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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International Clinical Development Study Director
Role: STUDY_DIRECTOR
Sanofi
Locations
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Minneapolis, Minnesota, United States
Brussels, , Belgium
Münster, , Germany
Bern, , Switzerland
Countries
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References
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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.
Other Identifiers
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PM211
Identifier Type: OTHER
Identifier Source: secondary_id
ACT6141
Identifier Type: -
Identifier Source: org_study_id
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