NCT03378531已完成2 期
An Open-label, Multicentre Extension Study to Evaluate the Long-Term Safety, Tolerability and Effects of Intravenous AEB1102 in Patients With Arginase I Deficiency Who Previously Received Treatment in Study CAEB1102-101A
Aeglea Biotherapeutics7 个研究点 分布在 4 个国家目标入组 14 人开始时间: 2017年12月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 7
- 主要终点
- Incidence of treatment-related adverse events
研究概览
简要总结
The purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.
详细描述
Purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete treatment in Study CAEB1102-101A without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing
- •Confirmation by the Investigator and the Sponsor determine that it is acceptable for the patient to continue dosing with AEB1102
- •If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment
- •If sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
- •Patient or legal guardian is able and willing to provide written informed consent and where required assent, and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification), prior to any screening procedures
排除标准
- •Clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances
研究组 & 干预措施
AEB1102
Experimental
Each patient may receive AEB1102 administered IV for up to approximately 4 years.
干预措施: AEB1102 (Drug)
结局指标
主要结局
Incidence of treatment-related adverse events
时间窗: up to 4 years
Incidence of treatment-related adverse events
次要结局
- Cmax Cmin(up to 4 years)
研究者
研究点 (7)
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