Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- number of patients with adverse effects during pregnancy
研究概览
简要总结
The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR) 2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar 2015-Mar 2024.
This study is a prospective observational study in which female patients undergoing Impavido who become pregnant during treatment or within 5 months after completing treatment can volunteer to provide information about their pregnancy and the outcome of the pregnancy.
详细描述
Objective: The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR) 2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar 2015-Mar 2024.
Study Design: This study is a prospective observational study in which female patients undergoing Impavido who become pregnant during treatment or within 5 months after completing treatment can volunteer to provide information about their pregnancy and the outcome of the pregnancy. Information will be collected from patient's provider of Impavido treatment, obstetrical treatment, and if applicable, the child's pediatrician.
Population: Leishmaniasis patients or patients who take Impavido off-label who become pregnant while taking Impavido or within 5 months after taking Impavido.
Drug Product:
Drug name: Impavido (50 mg capsules). Dosing regimen: as per the Impavido Product Label (PL)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has the subject received Impavido?
- •Is the subject a female?
- •Did the subject become pregnant during Impavido treatment or within 5 months after completing treatment?
- •Did the subject or legal guardian give consent/assent for the study and to collect data from her physicians?
排除标准
- 未提供
研究组 & 干预措施
miltefosine patients that become pregnant
干预措施: Miltefosine (Drug)
结局指标
主要结局
number of patients with adverse effects during pregnancy
时间窗: 9 months
number of patients with adverse pregnancy outcome
时间窗: 9 months
number of patients with adverse fetal outcome
时间窗: at birth
次要结局
未报告次要终点