Intermittent ClaudicationPhase 2WALKNCT00117650
Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication
A Phase 2 study testing Ad2/HIF-1α/VP16 in people with Intermittent Claudication and Peripheral Vascular Disease, run by Genzyme, a Sanofi Company at 47 sites in 3 countries.
Trial summary
The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Intermittent Claudication, Peripheral Vascular Disease, Atherosclerosis
- What is being tested?
- Ad2/HIF-1α/VP16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 47 sitesin 3 countries
- Study dates
- Feb 2005to Mar 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 40 to 80 years of age, inclusive.
- Clinical diagnosis of PAD, secondary to atherosclerosis, in both lower limbs, confirmed by objective evidence: An ankle-brachial index (ABI) of ≤ 0.90 at rest in at least 1 lower limb (Note: The index limb must be ≤ 0.90 at rest.); The ABI after exercise must be reduced by ≥ 20% from the ABI at rest in the index leg (the most symptomatic leg during the treadmill testing). The post-exercise ABI will also be performed on the other leg if the resting ABI > 0.90. A patient may be eligible for the study with a resting ABI in the non-index limb > 0.90 if: a. The post-exercise ABI in the non-index leg is also reduced by greater than or equal to 20% OR; b. A medically significant stenosis (defined as ≥ 50%) of a femoropopliteal or infrapopliteal artery is present, as documented via an imaging study (such as MR, conventional angiography, duplex ultrasound, or CT); If the ABI cannot be measured in either leg (due to non-compressible arteries), then a toe-brachial index (TBI) of ≤ 0.70 may be used in its place to confirm PAD.
- Symptoms of severe intermittent claudication (IC) in at least 1 lower limb persisting for ≥ 6 months
- Patients with a peak walking time (PWT) of 1 to 12 minutes (inclusive) using the standardized exercise treadmill test at each of the 2 consecutive treadmill tests performed at least a week apart during the Screening period.
- During Screening, patients must demonstrate consistency of PWTs between 2 standardized exercise treadmill tests (Walk 1 and Walk 2) performed at least 1 week apart.
- Consistency of the PWT between the 2 visits is achieved if the difference between PWT at Walk 1 and Walk 2 is ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT).
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- If the difference between PWT at Walk 1 and Walk 2 is > 25% of the higher of the 2 PWTs, a third treadmill test (Walk 3) may be performed at the discretion of the Principal Investigator between 7 and 14 days following Walk 2. The variability in PWT warranting the performance of Walk 3 must be secondary to circumstances that may contribute to the observed variation (e.g., prior exertion, inconsistent timing, ingestion of a meal within 4 hours, etc). To qualify for the study, the difference between PWT of either Walk 1 or Walk 2 as compared with Walk 3 must be ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT). The decision whether Walk 1 or Walk 2 will be used for comparison with Walk 3 will be made prospectively and reviewed with the Sponsor.
- An acceptable mean PWT must be achieved within 4 weeks of treatment administration.
- Patients have been considered for other potential treatment options including exercise rehabilitation, smoking cessation, and pharmacological therapy prior to Enrollment.
- Claudication severity, concomitant medications for the treatment of CAD, PAD, and IC, smoking status and exercise habits should be clinically stable for 3 months prior to Enrollment.
- Patients who are committed to following the protocol requirements as evidenced by written informed consent.
Who cannot join
- Patients with either current or any history of Critical Limb Ischemia (CLI; that is, patients classified as Rutherford Category 4 [ischemic rest pain], Rutherford Category 5 [non-healing ischemic ulcers and minor tissue loss], or Rutherford Category 6 [non-healing ischemic ulcers and major tissue loss]).
- Patients in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory non-atherosclerotic disorder (eg, thromboangiitis obliterans [Buerger's Disease]) and systemic sclerosis [both limited and diffuse forms]).
- A PAD-specific surgical revascularization procedure within 6 months of enrollment or a PAD-specific percutaneous procedure within 3 months of enrollment, or patients likely to require a PAD-specific revascularization procedure within 6 months after Enrollment.
- Patients with aortoiliac disease that limits inflow in either leg: a. Patients with concomitant aortoiliac disease (i.e., patients with a significant component of inflow disease in the distal aorta, common or external iliac, or proximal common femoral artery) as assessed by an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) performed within 1 year prior to Enrollment. If subject has had a bypass after the imaging study, then documentation of graft patency is required within 6 months prior to Enrollment; b. If it is suspected at Screening that a patient has aortoiliac disease based on vascular examination, an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) must be performed to rule it out if there is not one available within the times specified above. If there is no suspicion of aortoiliac disease in the Principal Investigator's judgment, an imaging test at Screening is not required for study purposes.
- Patients in whom walking impairment due to pain in the index leg is the result of these nonatherosclerotic comorbid conditions: venous claudication, chronic compartment syndrome, peripheral nerve pain (e.g., severe peripheral neuropathy), pseudoclaudication caused by spinal cord compression, or acute limb ischemia which, in the Principal Investigator's judgment are severe enough to confound the assessment of the patient's IC.
- Conditions other than IC of significant severity that could confound PWT on the standardized exercise treadmill test causing premature or inconsistent termination of exercise (e.g., angina pectoris, heart failure [New York Heart Association {NYHA} Classes III and IV], respiratory disease [e.g., chronic obstructive pulmonary disease], orthopedic disease, neurological disorders, rheumatologic disorders [e.g., severe degenerative joint diseases], dyspnea, fatigue, prior lower limb amputation, including amputations proximal to the metatarsal or phalangeal joints).
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- Presence or history of cancer within 5 years of enrollment or not current with recommended screening guidelines for colorectal, lung, prostate, breast, cervical, and uterine cancers, with the exception of low grade and fully resolved non-melanoma skin malignancy.
- Patients with a well-defined clinical or genetic disorder predisposing to malignancy should be excluded (e.g., von Hippel Lindau, familial polyposis coli, BRCA1, BRCA2, etc).
- Patients with baseline funduscopic evidence of active proliferative diabetic retinopathy, preproliferative diabetic retinopathy, or wet AMD AND/OR Patients with a history of treatment for active proliferative diabetic retinopathy or wet AMD within 5 years of enrollment.
- Diabetes type 1 (juvenile onset)
- Poorly controlled type 2 diabetes (ie, HbA1C >10%) at Screening
- Active hepatitis defined as clinically significant increase in liver enzymes (ie, 3 times the ULN) or other current infectious disease
- Patients with symptoms of respiratory infection at time of Screening and/or randomization period and/or patients who have been on systemic or oral antibiotics for active infection within 2 weeks of study drug administration.
- Patients with clinically significant abnormal hematology (eg, hematocrit < 30%, white blood cell count > 14,000), blood chemistry, renal, hepatic, or other laboratory parameters that could be the result of an underlying malignancy or systemic infection (e.g., serum creatinine ≥ 2.5 mg/dL), as judged by the investigator.
- Patients with the following comorbidities who may not be healthy enough to successfully complete all protocol requirements or in whom results may be particularly difficult to assess: Concurrent severe congestive heart failure (NYHA Classes III and IV); Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within 4 weeks before enrollment; Coronary artery bypass grafting or percutaneous coronary intervention within 3 months before enrollment; A renal and/or carotid revascularization procedure within 1 month of enrollment; Transient ischemic attack within 3 months before enrollment; Deep vein thrombosis within 3 months before enrollment; Severe chronic obstructive pulmonary disease (room air arterial PO2 < 60 mmHg or PCO2 > 50 mmHg, or abnormal pulmonary function tests (FEV1 < 1.2 L/sec); Thrombocytopenia (defined as platelet count < 100,000/mm3); Undergoing hemodialysis; Patients with immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy; Neurological dementia (i.e., Alzheimer's Disease); Hemorrhagic stroke
- Patients with a known allergy to the vehicle, placebo control, or any other medications or imaging agents required for participation in this study.
- Fertile women who are pregnant (as confirmed by a serum pregnancy test at the Screening Visit and a urine pregnancy test at Day 0 prior to study drug administration), nursing, or using either no or an inadequate form of contraception.
- Fertile men and women who are not willing to use barrier-type contraception for at least 90 days post-treatment.
- Patients with a recent history of alcoholism or drug abuse, or severe emotional, behavioral or psychiatric problems, who may not be able to adequately comply with the requirements of the study.
- Patients receiving experimental medications or participating in another study using an experimental drug or experimental procedure within 30 days of enrollment into this study.
- Patients previously enrolled in a prior angiogenic gene therapy clinical study, unless patient was a known placebo patient.
Trial locations and contacts
47 sites in 3 countries.
47 sites in 3 countries
United States35 sites
Saint Joseph's Research Institute
Atlanta, Georgia, 30342
Palm Beach Heart Institute
Atlantis, Florida, 33462
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Caritas St. Elizabeth's Medical Center, CCP4C
Boston, Massachusetts, 02135
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Medical Center
Dallas, Texas, 75246
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Henry Ford Hospital
Detroit, Michigan, 48126
Duke University Medical Center
Durham, North Carolina, 27705
Baylor College of Medicine
Houston, Texas, 77030
The Care Group at the Heart Center
Indianapolis, Indiana, 46290
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Ochsner Clinic Foundation
Metairie, Louisiana, 70002
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55415
New York University School of Medicine
New York, New York, 10003
Mount Sinai School of Medicine
New York, New York, 10029
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73190
VA Palo Alto Health Care System
Palo Alto, California, 94304
Baptist Health Care
Pensacola, Florida, 32522
Oregon Health & Science University
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642
University of California at Davis
Sacramento, California, 95817
Peripheral Vascular Associates
San Antonio, Texas, 78205
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, 32701
Saint Louis University Hospital
St Louis, Missouri, 63104
Stanford University School of Medicine
Stanford, California, 94305
University of South Florida
Tampa, Florida, 33606
Jobst Vascular Center
Toledo, Ohio, 43606
Medical University of Ohio
Toledo, Ohio, 43614
The Washington Hospital Center
Washington D.C., District of Columbia, 20010
Germany6 sites
Ev. Krankenhaus Königin Elisabeth
Berlin, 10365
Charité Campus Benjamin Franklin
Berlin, 12203
Klinikum Karlsbad Langensteinbach gGmbH
Karlsbad, 76307
Universitätsklinikum Schleswig Holstein/Campus Luebeck
Lübeck, 23538
Klinikum Grosshadern
Munich, 81377
Universitätsklinikum Munster
Münster, 48149
United Kingdom6 sites
Belfast City Hospital
Belfast, BT9 7AB
Selly Oak Hospital
Birmingham, B29 6JD
Ninewells Hospital & Medical School
Dundee, DD1 9SY
Hull Royal Infirmary
Hull, HU3 2JZ
St. George's Hospital and Medical School
London, SW17 0QT
Ealing Hospital
Southall, Middlesex, UB1 3HW
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 in Patients With Intermittent Claudication
The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD).
Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.
Read the detailed description
This Phase 2 gene transfer study will look at whether different doses of Ad2/HIF-1α/VP16 can be tolerated safely by direct injection into the leg muscles where the blood flow is not sufficient to meet the oxygen demands of the leg muscles. The study will also assess whether patients who receive the investigational drug product are able to increase their maximal walking time using a standardized treadmill walking test.
The study design is a randomized, double-blind, placebo-controlled, parallel group, multi-center, Phase 2 dose-selection study. Seventy-five patients will be enrolled into each of 4 study drug groups (3 groups of Ad2/HIF-1α/VP16 gene transfer and 1 placebo group) for a total of 300 patients overall. Three different doses of Ad2/HIF-1α/VP16 gene transfer will be studied. The dose range was previously tested in animals and in the Phase 1 human studies. A placebo group is included in the study to compare safety and efficacy of different doses of Ad2/HIF-1α/VP16 with placebo. Each patient will receive a single set of 20 injections (100 μL each) of gene transfer or placebo in one administration to each leg for a total of 40 injections.
- Being tested
- Ad2/HIF-1α/VP16, Saline (Placebo Control)
- Keywords
- leg pain, gene transfer, angiogenesis, Phase 2, Genzyme, peripheral arterial disease
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases, Atherosclerosis, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad2/HIF-1α/VP16Biological
Also called HIF-1alpha
a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections
Ad2/HIF-1α/VP16Biological
Also called HIF-1alpha
one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
Ad2/HIF-1α/VP16Biological
Also called HIF-1alpha
a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
Saline (Placebo Control)Other
a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Active comparator | 2 x 10^9 vp (viral particles) Receives: Biological: Ad2/HIF-1α/VP16 |
| Middle Dose | Active comparator | 2 x 10^10 vp Receives: Biological: Ad2/HIF-1α/VP16 |
| High Dose | Active comparator | 2 x 10^11 vp Receives: Biological: Ad2/HIF-1α/VP16 |
| Placebo | Placebo comparator | (PBS + 10% sucrose + 0.02% polysorbate 80) Receives: Other: Saline (Placebo Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Walking Time
Measured: at 6 months
Secondary outcomes (4)
Peak walking time
Measured: at 3 months and at 1 year
Claudication onset time
Measured: at 3 months, 6 months, and at 1 year
Quality of life questionnaires
Measured: at 3 months, 6 months, 1 year
Resting ankle brachial index
Measured: at 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2005 (estimated)
- Study startFeb 2005
- Primary completionSep 2008
- Study completionMar 2010
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 Intermittent ClaudicationStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117650
- Sponsor's protocol ID
- PADHIF00704
- Other IDs
- 2004-002508-13, 2004
- Acronym
- WALK
- Status last verified
- Mar 2015
- First submitted
- 30 Jun 2005
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Creager MA, Olin JW, Belch JJ, Moneta GL, Henry TD, Rajagopalan S, Annex BH, Hiatt WR. Effect of hypoxia-inducible factor-1alpha gene therapy on walking performance in patients with intermittent claudication. Circulation. 2011 Oct 18;124(16):1765-73. doi: 10.1161/CIRCULATIONAHA.110.009407. Epub 2011 Sep 26.
PubMed 21947297
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT00117650
- Acronym / sponsor ID
- WALK / PADHIF00704
- Keywords
- leg pain, gene transfer, angiogenesis, Phase 2, Genzyme, peripheral arterial disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Jul 2005 (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 purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD).
Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.
Detailed description
This Phase 2 gene transfer study will look at whether different doses of Ad2/HIF-1α/VP16 can be tolerated safely by direct injection into the leg muscles where the blood flow is not sufficient to meet the oxygen demands of the leg muscles. The study will also assess whether patients who receive the investigational drug product are able to increase their maximal walking time using a standardized treadmill walking test.
The study design is a randomized, double-blind, placebo-controlled, parallel group, multi-center, Phase 2 dose-selection study. Seventy-five patients will be enrolled into each of 4 study drug groups (3 groups of Ad2/HIF-1α/VP16 gene transfer and 1 placebo group) for a total of 300 patients overall. Three different doses of Ad2/HIF-1α/VP16 gene transfer will be studied. The dose range was previously tested in animals and in the Phase 1 human studies. A placebo group is included in the study to compare safety and efficacy of different doses of Ad2/HIF-1α/VP16 with placebo. Each patient will receive a single set of 20 injections (100 μL each) of gene transfer or placebo in one administration to each leg for a total of 40 injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Active comparator | Biological: Ad2/HIF-1α/VP162 x 10^9 vp (viral particles) |
| Middle Dose | Active comparator | Biological: Ad2/HIF-1α/VP162 x 10^10 vp |
| High Dose | Active comparator | Biological: Ad2/HIF-1α/VP162 x 10^11 vp |
| Placebo | Placebo comparator | Other: Saline (Placebo Control)(PBS + 10% sucrose + 0.02% polysorbate 80) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females 40 to 80 years of age, inclusive.
- Clinical diagnosis of PAD, secondary to atherosclerosis, in both lower limbs, confirmed by objective evidence: An ankle-brachial index (ABI) of ≤ 0.90 at rest in at least 1 lower limb (Note: The index limb must be ≤ 0.90 at rest.); The ABI after exercise must be reduced by ≥ 20% from the ABI at rest in the index leg (the most symptomatic leg during the treadmill testing). The post-exercise ABI will also be performed on the other leg if the resting ABI > 0.90. A patient may be eligible for the study with a resting ABI in the non-index limb > 0.90 if: a. The post-exercise ABI in the non-index leg is also reduced by greater than or equal to 20% OR; b. A medically significant stenosis (defined as ≥ 50%) of a femoropopliteal or infrapopliteal artery is present, as documented via an imaging study (such as MR, conventional angiography, duplex ultrasound, or CT); If the ABI cannot be measured in either leg (due to non-compressible arteries), then a toe-brachial index (TBI) of ≤ 0.70 may be used in its place to confirm PAD.
- Symptoms of severe intermittent claudication (IC) in at least 1 lower limb persisting for ≥ 6 months
- Patients with a peak walking time (PWT) of 1 to 12 minutes (inclusive) using the standardized exercise treadmill test at each of the 2 consecutive treadmill tests performed at least a week apart during the Screening period.
- During Screening, patients must demonstrate consistency of PWTs between 2 standardized exercise treadmill tests (Walk 1 and Walk 2) performed at least 1 week apart.
Key exclusion criteria (21 listed)
- Patients with either current or any history of Critical Limb Ischemia (CLI; that is, patients classified as Rutherford Category 4 [ischemic rest pain], Rutherford Category 5 [non-healing ischemic ulcers and minor tissue loss], or Rutherford Category 6 [non-healing ischemic ulcers and major tissue loss]).
- Patients in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory non-atherosclerotic disorder (eg, thromboangiitis obliterans [Buerger's Disease]) and systemic sclerosis [both limited and diffuse forms]).
- A PAD-specific surgical revascularization procedure within 6 months of enrollment or a PAD-specific percutaneous procedure within 3 months of enrollment, or patients likely to require a PAD-specific revascularization procedure within 6 months after Enrollment.
- Patients with aortoiliac disease that limits inflow in either leg: a. Patients with concomitant aortoiliac disease (i.e., patients with a significant component of inflow disease in the distal aorta, common or external iliac, or proximal common femoral artery) as assessed by an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) performed within 1 year prior to Enrollment. If subject has had a bypass after the imaging study, then documentation of graft patency is required within 6 months prior to Enrollment; b. If it is suspected at Screening that a patient has aortoiliac disease based on vascular examination, an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) must be performed to rule it out if there is not one available within the times specified above. If there is no suspicion of aortoiliac disease in the Principal Investigator's judgment, an imaging test at Screening is not required for study purposes.
- Patients in whom walking impairment due to pain in the index leg is the result of these nonatherosclerotic comorbid conditions: venous claudication, chronic compartment syndrome, peripheral nerve pain (e.g., severe peripheral neuropathy), pseudoclaudication caused by spinal cord compression, or acute limb ischemia which, in the Principal Investigator's judgment are severe enough to confound the assessment of the patient's IC.
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 |
|---|---|---|
| Ad2/HIF-1α/VP16Also: HIF-1alphaa one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections | Biological | Low Dose |
| Ad2/HIF-1α/VP16Also: HIF-1alphaone time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections. | Biological | Middle Dose |
| Ad2/HIF-1α/VP16Also: HIF-1alphaa one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections. | Biological | High Dose |
| Saline (Placebo Control)a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections. | Other | Placebo |
Primary outcome
Peak Walking Time
Time frame: at 6 months
4 secondary outcomes
Peak walking time
Time frame: at 3 months and at 1 year
Claudication onset time
Time frame: at 3 months, 6 months, and at 1 year
Quality of life questionnaires
Time frame: at 3 months, 6 months, 1 year
Resting ankle brachial index
Time frame: at 3 months, 6 months, 1 year
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 3 Apr 2015.
- Derived from this study: PubMed 21947297Creager MA, Olin JW, Belch JJ, Moneta GL, Henry TD, Rajagopalan S, Annex BH, Hiatt WR. Effect of hypoxia-inducible factor-1alpha gene therapy on walking performance in patients with intermittent claudication. Circulation. 2011 Oct 18;124(16):1765-73. doi: 10.1161/CIRCULATIONAHA.110.009407. Epub 2011 Sep 26.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
47 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad2/HIF-1α/VP16 in people with Intermittent Claudication and Peripheral Vascular Disease, run by Genzyme, a Sanofi Company at 47 sites in 3 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 11 inclusion and 21 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Germany, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Peak Walking Time (time frame: at 6 months). 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 NCT00117650, 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 3 Apr 2015.