NCT03472040已完成2 期
An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 387
- 试验地点
- 2
- 主要终点
- Safety & Tolerability
研究概览
简要总结
This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Subjects with HAE Type I or II who either have participated in a previous BCX7353 study or, in selected countries, in the opinion of the Investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks.
- •Access to appropriate medication for treatment of acute attacks
- •Acceptable effective contraception
- •Written informed consent
排除标准
- •Pregnancy or breast-feeding
- •Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study
- •Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study
- •Discontinuation of study drug due to a hypersensitivity reaction BCX7353 in a prior study
- •Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
- •Unacceptable noncompliance in a previous BCX7353 study (if applicable) as assessed by the Sponsor or Investigator
- •Investigational drug exposure, other than BCX7353, within 30 days prior to the screening visit (or baseline if no screening visit)
研究组 & 干预措施
BCX7353 150 mg once daily
Experimental
干预措施: BCX7353 (Drug)
结局指标
主要结局
Safety & Tolerability
时间窗: Up to 96 weeks (US) / 216 weeks (Rest of World (ROW)).
The number and percentage of subjects with treatment-emergent adverse events.
次要结局
- Incidence of Acute Attacks of Angioedema in Subjects During Treatment(Up to 96 weeks (US) / 216 weeks (ROW))
- The Durability of Response to Treatment(Up to 96 weeks (US) / 216 weeks (ROW))
- Patient Reported Quality of Life (QoL) During Treatment(Up to 96 weeks (US) / 216 weeks (ROW))
- Patient's Satisfaction With Medication During Long Term Administration of Berotralstat(Up to 96 weeks (US) / 216 weeks (ROW))
研究者
研究点 (2)
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