EUCTR2020-003918-12-IT进行中（未招募）1 期
An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema - CSL312_3002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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:
- •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
排除标准
- •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
- •6. Pregnant, breastfeeding, or not willing to cease breastfeeding
研究者
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