Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.

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Detailed Description

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Restenosis of peripheral artery lesions remains a challenging problem to overcome after percutaneous revascularization of atherosclerotic disease in the femoropopliteal arterial system. Rates of restenosis are as high as 60% after a year. Treatment options include medical therapy, angioplasty, arthrectomy and stent placement. The heterogeneity of disease between patients, variable length of target lesions and presence of unpredictable physical forces requires individualized treatment plans.

Vascular response to injury appears to play an important role in the development of restenosis. IL-1α is a potent inflammatory cytokine that plays a central role in vascular inflammation and vascular smooth muscle proliferation--both in acute and chronic injury. CV-18C3 antagonizes the biologic activity of IL-1α and is theorized to prevent the early IL-1α mediated inflammation that leads to vascular smooth muscle hypertrophy and restenosis, as well as the late IL-1α mediated atherosclerotic plaque formation.

Conditions

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Patients Undergoing Repeat Peripheral Artery Revascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CV-18C3 and standard of care

Group Type EXPERIMENTAL

CV-18C3

Intervention Type DRUG

3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration

Standard of Care

Intervention Type PROCEDURE

standard of care

Percutaneous revascularization

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type PROCEDURE

Interventions

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CV-18C3

3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration

Intervention Type DRUG

Standard of Care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Have suspected superficial femoro-popliteal artery occlusion due to lower extremity pain with exercise or at rest and are undergoing a planned arteriogram.
* Subjects will be randomized after angiographic evidence of qualifying lesion

Exclusion Criteria

* Acute critical limb ischemia
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No