An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema - CSL312_3002

CSL Behring LLC0 个研究点目标入组 161 人开始时间: 2024年3月8日最近更新: 2024年8月21日

适应症

试验速览

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•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

•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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