Active Drug Surveillance Program of Ferriprox Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ApoPharma
- 入组人数
- 294
- 试验地点
- 14
- 主要终点
- Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients.
研究概览
简要总结
Observational, open label, prospective, multi-center, post-marketing drug surveillance program.
详细描述
A post-marketing, drug surveillance program evaluating the use, monitoring, benefits and adverse effects of Ferriprox under clinical conditions in newly treated patients.
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 who started Ferriprox therapy less than one month or are to initiate Ferriprox therapy at the time of enrolment into the program.
排除标准
- •Patients treated with Ferriprox for more than one month prior to enrolment.
结局指标
主要结局
Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients.
时间窗: Baseline to 12 Months
Evaluation of dose of Ferriprox includes the frequency of administration of chelator(s).
Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients.
时间窗: Baseline to 12 Months
Evaluation of how Ferriprox is prescribed/received by the patient: as monotherapy, simultaneous with deferoxamine, alternate with deferoxamine, simultaneous with deferasirox, alternate with deferasirox.
次要结局
- Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice.(Baseline to 12 Months)
- Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice.(Baseline to 12 Months)