A randomized, double-blind, placebo controlled multiple dose study of subcutaneous ACZ885 for the treatment of abdominal aortic aneurysm
- Conditions
- Abdominal aortic aneurysmdilation of the aorta in the abdomen10002363
- Registration Number
- NL-OMON38947
- Lead Sponsor
- ovartis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
* Male and female subjects age *45 years of age
* Infrarenal abdominal aortic aneurysm with maximum diameter:
* for men *40mm and *50mm
* for women *38mm and *48mm
* On a stable medical regimen for at least 2 weeks prior to dosing
* Have an evaluable ultrasound image at screening for thequantitative determination of the AAA size
* At screening and pre-dose on Day 1, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes.
Sitting vital signs should be within the following ranges:
oral body temperature between 35.0-37.5°C
systolic blood pressure, 90-170 mm Hg
diastolic blood pressure, 50-100 mm Hg
pulse rate, 40 - 100 bpm
*Known diabetes by medical history, a HbA1c of *6.5% at screening, or on an active diabetic medical regimen
* Women of child bearing potential unless using effective methods of contraception
* Subjects on the following medications:
1) Chronic systemic steroid treatment or other systemic immunosuppression. Use oftopical, ophthalmic or inhaled steroids at doses not considered to have systemic effects is allowed. Temporary use of steroids (e.g., for asthma exacerbations) are allowed if last steroid use is more than 1 month prior to screening and the anticipated frequency of requiring such steroids are less than once per year.
2) Any biologic drugs targeting the immune system, e.g., TNF blockers, anakinra, rituximab, abatacept, tocilizumab. Any previous history of the use of such biologics is also an excluded.
* Presence of a non-healing wound or infection, including active urinary tract infections, or any recent process requiring significant tissue healing per investigator assessment. Other active infections
within 2 weeks will be excluded.
* Previous infra-renal aortic surgery
* Known aortic dissection
* Subjects should exhibit no signs of clinically concerning unstable acceleration of AAA size or growth rate at the time of enrollment per investigator assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy variables will be the AAA size and growth rate (change from<br /><br>baseline AAA size per year) from the ultrasound assessment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Volumetric and biophysical profiling data from CT scan of AAA, as well as<br /><br>hs-CRP, IL-6, total IL-1* and immunoglobulins.<br /><br>The number and percentage of subjects with major cardiovascular events (MACE),<br /><br>acute or<br /><br>elective aneurysm repair, aneurysm rupture, death (any cause) and any other<br /><br>clinical events of<br /><br>special interest over the 12-month treatment period.<br /><br>Safety parameters: all vital signs data, ECG data, laboratory data, adverse<br /><br>events and immunogenicity data.</p><br>