NCT02399839终止不适用
Global Lomitapide Pregnancy Exposure Registry
Amryt Pharma1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pregnancy
研究概览
简要总结
To evaluate the outcomes of pregnancy in women treated with lomitapide.
详细描述
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.
排除标准
- •Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.
结局指标
主要结局
Pregnancy
时间窗: 2 Years
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.
次要结局
未报告次要终点
研究者
研究点 (1)
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