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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01270945
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : June 24, 2014
Information provided by (Responsible Party):
XBiotech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patients Undergoing Repeat Peripheral Artery Revascularization Drug: CV-18C3 Procedure: Standard of Care Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open Label,Randomized Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody(CV-18C3)in Reducing Restenosis in Patients Undergoing Percutaneous Femoro-popliteal Revascularization.
Study Start Date : June 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: CV-18C3 and standard of care
CV-18C3 and standard of care
Drug: CV-18C3
3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration
Procedure: Standard of Care
Active Comparator: standard of care
Percutaneous revascularization
Procedure: Standard of Care

Primary Outcome Measures :
  1. Safety and tolerability of CV-18C3 [ Time Frame: 1 year ]
    adverse events, vitals signs, physical examination results and clinical laboratory values

Secondary Outcome Measures :
  1. Time to restenosis and restenosis rates compared between CV-18C3 and controls [ Time Frame: 1 year ]
    Efficacy determination will be derived from observed rates of target vessel occlusion, time to occlusion, incidence of target vessel revascularization procedures and incidence of major adverse cardiovascular events (MACE). ABI measurements and quality of life questionnaire scores will also be collected. Treated subjects will be compared to those randomized to no treatment.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01270945

United States, California
Sutter Heart & Vascular Institute
Sacramento, California, United States, 95819
United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
River City Clinical Research
Jacksonville, Florida, United States, 32207
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Mediquest Research Group
Ocala, Florida, United States, 34471
United States, Georgia
John D. Archbold Memorial Hospital
Thomasville, Georgia, United States, 31799
United States, Ohio
Univeristy of Cincinnati University Hospital
Cincinnati, Ohio, United States, 45267
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
XBiotech, Inc.
Principal Investigator: Hosam El-Sayed, M.D., Ph.D. Methodist Cardiovascular Surgery Associates

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: XBiotech, Inc. Identifier: NCT01270945     History of Changes
Other Study ID Numbers: 2010-PT017
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs