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

NCT00424866 | Unknown Phase 1 FDA Drug

• 1 other identifier: CVBT-2006-PAD-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Arterial Disease; Stenosis; Intermittent Claudication

Keywords

Peripheral Arterial Disease; Ischemia; Intermittent Claudication

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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

  From enrollment through study completion, an average of 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The dosing groups correspond to total doses of 0 µg/kg of FGF-1.

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.

Drug: FGF-1

Interventions

FGF-1 DRUG

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

Also known as: Acidic FGF

Human FGF-1

Placebo DRUG

Vehicle: 0 µg/kg

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed.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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CardioVascular BioTherapeutics, Inc.: lead

Study Sites (1)

CVBT Info

Dallas, Texas, 75238, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Constriction, Pathologic; Intermittent Claudication; Ischemia

Interventions

Fibroblast Growth Factor 1

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Warren Sherman, MD

CONTACT

(972) 681-9368; wsherman@cvbt.com

Adam Nedella

CONTACT

(972) 681-9368; anedella@cvbt.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 22, 2007
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)