Patients Undergoing Repeat Peripheral Artery RevascularizationPhase 2NCT01270945
Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.
A Phase 2 study testing CV-18C3 in people with Patients Undergoing Repeat Peripheral Artery Revascularization, run by Janssen Research & Development, LLC at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Repeat Peripheral Artery Revascularization
- What is being tested?
- CV-18C3
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Jun 2011to 30 Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
JFK Medical Center
Atlantis, Florida, 33462
Univeristy of Cincinnati University Hospital
Cincinnati, Ohio, 45267
Methodist Hospital
Houston, Texas, 77030
River City Clinical Research
Jacksonville, Florida, 32207
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Mediquest Research Group
Ocala, Florida, 34471
Sutter Heart & Vascular Institute
Sacramento, California, 95819
John D. Archbold Memorial Hospital
Thomasville, Georgia, 31799
About this study
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.
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.
Read the 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.
- Being tested
- CV-18C3, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV-18C3Drug
3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration
Standard of CareProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CV-18C3 and standard of care | Experimental | CV-18C3 and standard of care Receives: Drug: CV-18C3; Procedure: Standard of Care |
| standard of care | Active comparator | Percutaneous revascularization Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CV-18C3
adverse events, vitals signs, physical examination results and clinical laboratory values
Measured: 1 year
Secondary outcomes (1)
Time to restenosis and restenosis rates compared between CV-18C3 and controls
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study start30 Jun 2011
- Primary completion30 Sep 2013
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Repeat Peripheral Artery RevascularizationStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hosam El-Sayed, M.D., Ph.D., Principal investigator, Methodist Cardiovascular Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270945
- Sponsor's protocol ID
- 2010-PT017
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2011
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
El Sayed H, Kerensky R, Stecher M, Mohanty P, Davies M. A randomized phase II study of Xilonix, a targeted therapy against interleukin 1alpha, for the prevention of superficial femoral artery restenosis after percutaneous revascularization. J Vasc Surg. 2016 Jan;63(1):133-41.e1. doi: 10.1016/j.jvs.2015.08.069. Epub 2015 Oct 1.
PubMed 26433546
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01270945
- Acronym / sponsor ID
- 2010-PT017
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2011 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CV-18C3 and standard of care | Experimental | Drug: CV-18C3, Procedure: Standard of CareCV-18C3 and standard of care |
| standard of care | Active comparator | Procedure: Standard of CarePercutaneous revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CV-18C33.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration | Drug | CV-18C3 and standard of care |
| Standard of Care | Procedure or surgery | CV-18C3 and standard of care, standard of care |
Primary outcome
Safety and tolerability of CV-18C3
Time frame: 1 year
adverse events, vitals signs, physical examination results and clinical laboratory values
1 secondary outcome
Time to restenosis and restenosis rates compared between CV-18C3 and controls
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 26433546El Sayed H, Kerensky R, Stecher M, Mohanty P, Davies M. A randomized phase II study of Xilonix, a targeted therapy against interleukin 1alpha, for the prevention of superficial femoral artery restenosis after percutaneous revascularization. J Vasc Surg. 2016 Jan;63(1):133-41.e1. doi: 10.1016/j.jvs.2015.08.069. Epub 2015 Oct 1.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hosam El-Sayed, M.D., Ph.D. principal investigator
Methodist Cardiovascular Surgery Associates
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CV-18C3 in people with Patients Undergoing Repeat Peripheral Artery Revascularization, run by Janssen Research & Development, LLC at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of CV-18C3 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.