NCT01467947已完成4 期
Prospective Open-label Uncontrolled Multi-center Post-marketing Study to Assess Inhibitory Antibody Formation in Subjects With Congenital C1-INH Deficiency and Acute Hereditary Angioedema (HAE) Attacks Treated With Berinert® , a C1-esterase Inhibitor
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies
研究概览
简要总结
This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treated intravenously with Berinert. Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. All subjects will receive 20 IU Berinert/kg body weight per attack.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congenital C1-INH deficiency (HAE type I or II) and assessed by the investigator to likely require intravenous (IV) Berinert treatment during the study period.
- •Male or female, ≥ 12 years of age at the time of signing informed consent.
- •Written informed consent for study participation obtained before undergoing any study specific procedures.
排除标准
- •Incurable malignancies in the last 6 months prior to study entry.
- •Acquired angioedema due to C1-INH deficiency.
- •All other types of angioedema not associated with C1-INH deficiency.
- •Use of any C1-INH products other than Berinert within 30 days before the study, or planned use during the study.
- •Immunization within 30 days prior to study entry.
- •Autoimmune conditions requiring use of immunosuppressants during the study.
- •Known or suspected hypersensitivity to C1-INH.
- •Participation in any of the previous Berinert studies from which anti-C1-INH antibody results were submitted to the Food and Drug Administration.
研究组 & 干预措施
Berinert
Experimental
干预措施: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection (Biological)
结局指标
主要结局
Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies
时间窗: Baseline to approximately 9 months
Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.
次要结局
- Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies(Baseline to approximately 9 months)
研究者
研究点 (4)
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