NCT02135705已完成不适用
LOWER: Lomitapide Observational Worldwide Evaluation Registry
Amryt Pharma144 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2014年3月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 144
- 主要终点
- Hepatic Abnormalities
研究概览
简要总结
This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
详细描述
To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all ages, including minors, who have initiated commercial treatment with lomitapide prior to or at time of registry enrolment.
- •Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures or paediatric patients with the consent of a parent or legal guardian.
- •Patients ≥7 years of age (or above the age determined by the IRB/EC and in accordance with the local regulations and requirements) must also provide written informed assent forms.
排除标准
- •Patients who are receiving lomitapide in clinical trials or through compassionate use, where patients are followed under a separate protocol.
- •Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received market authorization in the country of participation, at time of lomitapide initiation and continuing to receive an investigational agent at time of registry enrolment. These patients may be enrolled if receiving lomitapide when the investigational agent is discontinued..
研究组 & 干预措施
Lomitapide
Lomitapide as prescribed by Physician.
干预措施: Lomitapide (Drug)
结局指标
主要结局
Hepatic Abnormalities
时间窗: patients will be followed for 10 years
to evaluate the occurrence of hepatic abnormalities
次要结局
- Gastrointestinal (GI) Events(patients will be followed for 10 years)
- Tumors(patients will be followed for 10 years)
- Events associated with coagulopathy(patients will be followed for 10 years)
- Major Adverse Cardiovascular Events (MACE) events(patients will be followed for 10 years)
- Death, including cause of death(patients will be followed for 10 years)
- Pregnancy(patients will be followed for 10 years)
- Serum lipid levels(patients will be followed for 10 years)
- Prescriber behavior(patients will be followed for 10 years)
研究者
研究点 (144)
Loading locations...
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