Back to resultsDose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication (TALISMAN 211)
Primary Purpose
Peripheral Arterial Occlusive Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
XRP0038 (NV1FGF)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusive Disease
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
placebo
NV1FGF 16 mg
NV1FGF 32 mg
Arm Description
4 administrations at 2-week interval of placebo solution
4 administrations at 2-week interval of 4mg at each administration
4 administrations at 2-week interval of 8mg at each administration
Outcomes
Primary Outcome Measures
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13
Secondary Outcome Measures
NV1FGF DNA 69 base pair (bp) in plasma
NV1FGF DNA 825 bp in plasma
FGF-1 in plasma
Anti-FGF1 antibodies in serum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01157871
Brief Title
Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
Acronym
TALISMAN 211
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Experimental
Arm Description
4 administrations at 2-week interval of placebo solution
Arm Title
NV1FGF 16 mg
Arm Type
Experimental
Arm Description
4 administrations at 2-week interval of 4mg at each administration
Arm Title
NV1FGF 32 mg
Arm Type
Experimental
Arm Description
4 administrations at 2-week interval of 8mg at each administration
Intervention Type
Drug
Intervention Name(s)
XRP0038 (NV1FGF)
Intervention Description
Pharmaceutical form:solution
Route of administration: intramuscular
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form:solution
Route of administration: intramuscular
Primary Outcome Measure Information:
Title
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
NV1FGF DNA 69 base pair (bp) in plasma
Time Frame
up to week 27
Title
NV1FGF DNA 825 bp in plasma
Time Frame
up to week 27
Title
FGF-1 in plasma
Time Frame
up to week 27
Title
Anti-FGF1 antibodies in serum
Time Frame
up to week 27
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
International Clinical Development Study Director
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Bruxelles
Country
Belgium
City
Münster
Country
Germany
City
Bern
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21716303
Citation
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.
Results Reference
derived
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Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
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