A randomized, double-blind, placebo controlled multiple dose study of subcutaneous ACZ885 for the treatment of abdominal aortic aneurysm

ovartis Pharma Services AG0 个研究点目标入组 100 人开始时间: 2013年10月29日最近更新: 2016年8月8日

适应症

试验速览

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•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•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

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