FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by CardioVascular BioTherapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
CardioVascular BioTherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00424866
First received: January 18, 2007
Last updated: April 7, 2014
Last verified: August 2013
  Purpose

FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.


Condition Intervention Phase
Peripheral Arterial Disease
Stenosis
Intermittent Claudication
Drug: FGF-1
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CardioVascular BioTherapeutics, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The main objective of this study is to evaluate the safety and tolerability of FGF-1 in patients with peripheral arterial disease and intermittent claudication. Vital signs, physical examinations, safety laboratory evaluations and total number of adverse events will be captured and analyzed accordingly.


Estimated Enrollment: 24
Study Start Date: December 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human FGF-1
The three dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.
Drug: FGF-1

Doses of FGF-1:

Vehicle: 0 µg/kg Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg

Other Name: Acidic FGF

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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.
  2. 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.
  3. Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.
  4. 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.
  5. 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.
  6. 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.
  7. Preexisting medication regime must be stable for 6 weeks preceding dosing.

Exclusion Criteria

  1. Evidence of critical leg ischemia, i.e. ischemic rest pain or ischemic ulceration
  2. Treadmill walking limited by conditions other than intermittent claudication including arthritis, angina and dyspnea
  3. Lower limb amputation of, or in, either leg including toes
  4. Evidence of limb ischemia from immunologic or inflammatory disorders
  5. Leg surgery or revascularization within past 6 months or peripheral angioplasty within past 3 months or anticipated during study
  6. Participation in any investigational device or drug trial within the past 6 months
  7. Myocardial infarction, unstable angina, stroke or ischemic attack within past 6 months
  8. New York Heart Association (NYHA) class II, III or IV heart failure, restrictive or hypertrophic cardiomyopathy or severe valvular disease
  9. QTc elongation greater than 450 ms in males or 460 ms in females
  10. PT (INR), PTT, urinalysis, thyroid function (T3, T4, TSH) outside normal limits
  11. Hemorrhage or thrombotic events (e.g. deep vein thrombosis) within past 6 months
  12. Thrombocytopenia (<100,000/µl), history of heparin-induced thrombocytopenia
  13. Major surgery with the past 6 months
  14. Positive proliferative retinopathy exam
  15. Present of any type of cancer or history of cancer except past (but not present) basal cell dermal carcinoma not on either leg
  16. Inflammatory or progressive fibrotic or myelofibrotic disorders
  17. Patients experiencing bacterial or viral infection (e.g. hepatitis or HIV) or who may otherwise be febrile
  18. Hemoglobin A1c(HgbA1c) of >8%
  19. Type I diabetes
  20. Total fasting cholesterol >200
  21. Uncontrolled hypertension (≥160 systolic or ≥100 diastolic pressure) or hypotension (<90 systolic or <60 diastolic pressure)
  22. Disease or drug (e.g. systemic corticosteroid) immuno-compromised
  23. Hepatic dysfunction as defined either by AST or ALT > 2.0 times the upper limit of normal
  24. Serum creatinine of ≥ 2.5 mg/dl
  25. Proteinuria (urine protein/creatinine ratio > 3)
  26. Antiproliferative drugs (e.g. thalidomide, hydroxyurea)
  27. Radiation therapy
  28. Implanted devices not compatible with strong magnetic fields
  29. Life expectance of less than 1 year
  30. Females who are premenopausal and not sterilized or using adequate birth control or are either pregnant, intend to become pregnant or are nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424866

Contacts
Contact: William R Hiatt, MD 1-303-860-9900

Locations
United States, North Carolina
Durham VA Hospital Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Brian Annex, MD    919-286-0411 ext 7258      
Sponsors and Collaborators
CardioVascular BioTherapeutics, Inc.
Investigators
Principal Investigator: Brian Annex, MD Durham VA Hospital
  More Information

No publications provided

Responsible Party: CardioVascular BioTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00424866     History of Changes
Other Study ID Numbers: CVBT-2006-PAD-01
Study First Received: January 18, 2007
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioVascular BioTherapeutics, Inc.:
Peripheral Arterial Disease
Ischemia
Intermittent Claudication

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Constriction, Pathologic
Intermittent Claudication
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on August 28, 2014