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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01270945
First received: January 4, 2011
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Patients Undergoing Repeat Peripheral Artery Revascularization
Drug: CV-18C3
Procedure: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by XBiotech, Inc.:

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


Secondary Outcome Measures:
  • Time to restenosis and restenosis rates compared between CV-18C3 and controls [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: June 2011
Study Completion Date: April 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01270945

Locations
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.
Investigators
Principal Investigator: Hosam El-Sayed, M.D., Ph.D. Methodist Cardiovascular Surgery Associates
  More Information

No publications provided

Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01270945     History of Changes
Other Study ID Numbers: 2010-PT017
Study First Received: January 4, 2011
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014