An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

CSL Behring LLC0 个研究点目标入组 150 人开始时间: 2021年2月4日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•1. Males and females aged = 12 years
•2. Diagnosed with clinically confirmed C1-INH HAE
•3. Experienced = 3 HAE attacks during the 3 months before Screening
•4. Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
•5. Experienced at least an average of 1 HAE attack per month during the Run-in Period
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
•2. Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
•3. Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
•4. Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
•5. Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
•6. Pregnant, breastfeeding, or not willing to cease breastfeeding

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