EUCTR2014-001054-42-CZ进行中（未招募）1 期
An open-label, randomized study to evaluate the long-term clinical safety and efficacy of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the prophylactic treatment of hereditary angioedema
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
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
- •Males or females aged 6 years or older.
- •A confirmed diagnosis of HAE type I or II.
- •HAE attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment.
- •For subjects who have used oral therapy for prophylaxis against HAE attacks within 3 months of first study visit: use of a stable regimen within 3 months of the first study visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 11
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Incurable malignancies.
- •Any clinical condition that will interfere with the evaluation of C1-INH therapy.
- •Clinically significant history of poor response to C1-esterase therapy for the management of HAE.
- •Suspected or confirmed diagnosis of acquired HAE or HAE with normal C1-INH.
- •Inability to have HAE managed pharmacologically with on-demand treatment.
研究者
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