Peripheral Arterial DiseasePhase 1/2NCT00424866
FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
A Phase 1/2 study testing FGF-1 in people with Peripheral Arterial Disease and Stenosis, run by Venturis Therapeutics, Inc. at 1 site in United States.
Trial summary
FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease, Stenosis, Intermittent Claudication
- What is being tested?
- FGF-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2028to 15 Dec 2030
- Phase
- Phase 1/2
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.
- Age must be ≥50 and ≤75 years of age with a life expectancy of > 1 year and leg survival > 6 months. Patients >75 and ≤80 years of age will be considered if they show no signs of cognitive or muscle function decline and are fully able to comply with the protocol.
- Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.
- Patients must have peripheral arterial disease, as confirmed by a resting ABI ≥0.40 and <0.90 based on at least one leg as measured using both the dorsal pedis and posterior tibial arteries.
- Stenosis of >70% up to total occlusion must be present in the popliteal artery and/or in the tibial peroneal trunk or at least 2 tibial arteries above the ankle without inflow limitation of the popliteal artery. Adequate popliteal inflow is defined as continuous flow from the abdominal aorta, iliac, common femoral and superficial femoral with any stenosis < 50% as determined either by intra-arterial DSA, CTA or Gd CE-MRA.
- The screening Gardner treadmill test peak walking times (PWT) must be >1 minute and < 12 minutes and limited by pain in one or both calves.
- Preexisting medication regime must be stable for 6 weeks preceding dosing.
Who cannot join
- Evidence of critical leg ischemia, i.e. ischemic rest pain or ischemic ulceration
- Treadmill walking limited by conditions other than intermittent claudication including arthritis, angina and dyspnea
- Lower limb amputation of, or in, either leg including toes
- Evidence of limb ischemia from immunologic or inflammatory disorders
- Leg surgery or revascularization within past 6 months or peripheral angioplasty within past 3 months or anticipated during study
- Participation in any investigational device or drug trial within the past 6 months
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- Myocardial infarction, unstable angina, stroke or ischemic attack within past 6 months
- New York Heart Association (NYHA) class II, III or IV heart failure, restrictive or hypertrophic cardiomyopathy or severe valvular disease
- QTc elongation greater than 450 ms in males or 460 ms in females
- PT (INR), PTT, urinalysis, thyroid function (T3, T4, TSH) outside normal limits
- Hemorrhage or thrombotic events (e.g. deep vein thrombosis) within past 6 months
- Thrombocytopenia (<100,000/µl), history of heparin-induced thrombocytopenia
- Major surgery with the past 6 months
- Positive proliferative retinopathy exam
- Present of any type of cancer or history of cancer except past (but not present) basal cell dermal carcinoma not on either leg
- Inflammatory or progressive fibrotic or myelofibrotic disorders
- Patients experiencing bacterial or viral infection (e.g. hepatitis or HIV) or who may otherwise be febrile
- Hemoglobin A1c(HgbA1c) of >8%
- Type I diabetes
- Total fasting cholesterol >200
- Uncontrolled hypertension (≥160 systolic or ≥100 diastolic pressure) or hypotension (<90 systolic or <60 diastolic pressure)
- Disease or drug (e.g. systemic corticosteroid) immuno-compromised
- Hepatic dysfunction as defined either by AST or ALT > 2.0 times the upper limit of normal
- Serum creatinine of ≥ 2.5 mg/dl
- Proteinuria (urine protein/creatinine ratio > 3)
- Antiproliferative drugs (e.g. thalidomide, hydroxyurea)
- Radiation therapy
- Implanted devices not compatible with strong magnetic fields
- Life expectance of less than 1 year
- Females who are premenopausal and not sterilized or using adequate birth control or are either pregnant, intend to become pregnant or are nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication
FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.
Read the detailed description
FGF-1 administered by intramuscular injection for the treatment of peripheral arterial disease with intermittent claudication. Eligible patients are allocated to one of three treatment arms. Patients within each dosing group will be randomized between study drug and vehicle control. Safety, pharmacokinetics, and cardiovascular improvement will be evaluated at day 1 and weeks 1, 4 and 12 post dosing.
- Being tested
- FGF-1, Placebo
- Keywords
- Peripheral Arterial Disease, Ischemia, Intermittent Claudication
- Medical subject headings
- Peripheral Arterial Disease, Constriction, Pathologic, Intermittent Claudication, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGF-1Drug
Also called Acidic FGF
Doses of FGF-1: 3 ug/kg; 10 ug/kg; 30 ug/kg
Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg
PlaceboDrug
Vehicle: 0 µg/kg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The dosing groups correspond to total doses of 0 µg/kg of FGF-1. Receives: Drug: Placebo |
| Human FGF-1 | Active comparator | The dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1. Receives: Drug: FGF-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability of i.m. injected Cardio Vascu Grow TM, a recombinant Human Fibroblast Growth Factor-1 (FGF-1-141)
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Measured: From enrollment through study completion, an average of 12 weeks
Change from baseline in safety laboratory measurements at 12 weeks
Safety laboratory evaluations on hematology, serum chemistry, and urinalysis
Measured: From enrollment through study completion, an average of 12 weeks
Secondary outcomes (1)
Plasma FGF-1 (1-141) pharmacokinetic measurements at pre-dose, 5, 15, and 30 minutes and at 1, 2, 4, 6, 10, and 24 hours
Pharmacokinetic plasma concentrations of FGF-1 (1-141)
Measured: From enrollment through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study start15 Oct 2028 (estimated)
- Primary completion5 Feb 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venturis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424866
- Sponsor's protocol ID
- CVBT-2006-PAD-01
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2007
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No