Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of patients cured
研究概览
简要总结
This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine (Impavido) in the US and who weigh > 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.
详细描述
Objective: The purpose of this observational study is to fulfill PMR 2127-4 for the miltefosine NDA (204684): implement a higher-weight-patient registry for the time period Mar 2015-Mar 2020.
Study Design: This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with Impavido in the US and who weigh > 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.
Population: Leishmaniasis patients treated with Impavido who weigh more than 75 kg.
Drug Product:
Drug name: Impavido (50 mg capsules). Dosing regimen: as per the Impavido Product Label
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Did the subject give consent to collect data from her or her physician?
- •Was the subject treated for leishmaniasis with miltefosine?
- •Does the subject weigh more than 75 kg?
排除标准
- 未提供
研究组 & 干预措施
Miltefosine
Miltefosine : target of 2.5 mg/kg/day for 28 days. Patients 45 kg or greater were to receive one 50 mg capsule 3 times daily for 28 consecutive days. This prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine in the United States who weighed >75 kg could volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.
干预措施: Miltefosine (Drug)
结局指标
主要结局
Number of patients cured
时间窗: 6 months
Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy
次要结局
- Number of patients with adverse effects(6 months)