EUCTR2004-001186-17-CZ进行中（未招募）1 期
Human pasteurized C1 esterase inhibitor concentrate (CE1145) in subjects with congenital C1-INH deficiency and acute abdominal or facial HAE attacks - C1-INH HAE study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
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
- •- Male and female subjects >= 6 years
- •- Documented congenital C1-INH deficiency with immunogenic and/or functional C1-INH level below the lower limit of the laboratory reference range (HAE type I or II); to be confirmed by central laboratory.
- •- Documented history of abdominal or facial attacks
- •- Acute abdominal or facial attack with moderate /severe intensity for no longer than
- •5.0 hours at the time of study medication administration
- •- Informed written consent has been obtained (signed by subject, or, in case of a minor, by his/her legally acceptable representative(s))
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Life expectancy < 6 months
- •- Incurable malignancies with metastases
- •- History of hypersensitivity to the study medication
- •- Acquired angioedema due to C1-INH deficiency (e. g., onset at age > 40 years, no family history of congenital C1-INH deficiency, low C1q level, and no known HAE mutation)
- •- All other types of angioedema not associated with C1-INH deficiency
- •(including e.g. anaphylactic angioedema)
- •- Abdominal pain caused by other pathology (e. g., appendicitis, myocardial infarction)
- •- End-stage liver disease (i.e., Child-Pugh-score B or C)
- •- Fever (> 38.3°C or 101.0 F)
- •- High white blood cell count (> 20.0 x 10 exp9/L )
- •- Pregnant women (pregnancy test required), women currently breast-feeding, or with the intention to breast feed
- •- Treatment with any other investigational drug (except IMP and any other drugs appropriate for the treatment of acute angioedema) 30 days before start of study treatment on Day 1.
- •- Treatment with any C1-INH concentrate or any other drugs appropriate for the treatment of acute angioedema within 7 days before start of study treatment on Day 1.
- •- Treatment with fresh frozen plasma or native plasma within 7 days before start of study treatment on Day 1.
- •- Treatment with ACE inhibitors within 4 weeks before start of study treatment on Day 1.
- •- Narcotic pain medication and/or anti-emetics between start of attack and administration of study medication.
- •- Evidence of narcotic seeking behavior and/or drug addiction (including alcohol abuse)
- •- Mental condition rendering the subject (or the subject’s legally acceptable representative(s)) unable to understand the nature, scope and possible consequences of the study
- •- Prior inclusion into this study
研究者
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