Uptravi® (SelexiPag): tHe usErs dRug rEgistry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 85
- 主要终点
- Using Electronic Medical Records, the change in Hemodynamics (by Right Heart Catherization), WHO FC and 6 Minute Walk Distance (by meters) from diagnosis to registry enrollment and to EOS will be measured/collected.
研究概览
简要总结
This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed patient informed consent form (ICF).
- •Patients ≥ 18 years of age at time of Uptravi initiation, and
- •Patients who initiate Uptravi:
- •at enrollment, or
- •less than or equal to 60 days prior to enrollment and have a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)
排除标准
- •Patients previously exposed to Uptravi treatment during a clinical trial.
- •Patients that previously discontinued Uptravi for any reason, prior to study enrollment (discontinuation defined as an interruption of therapy greater than or equal to 30 days).
- •Patients enrolled in a blinded clinical trial or in a clinical trial involving an unapproved drug.
结局指标
主要结局
Using Electronic Medical Records, the change in Hemodynamics (by Right Heart Catherization), WHO FC and 6 Minute Walk Distance (by meters) from diagnosis to registry enrollment and to EOS will be measured/collected.
时间窗: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
To describe demographics and disease characteristics of patients treated with Uptravi.
The initial dose (in micrograms), dose at selected intervals (in days), highest dose, maintenance dose, time between titrations, time from initiation to maintenance dose (in days) and total duration of exposure to Uptravi (in days) will be collected.
时间窗: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
To describe the dosing regimens and titration of Uptravi, including any transition from other PAH specific therapies to Uptravi and from Uptravi to other prostanoids.
Occurrence of AEs and SAEs (incl. hospitalizations), discontinuation of Uptravi and reason for stopping and occurrence of all-cause death by relationship to PAH.
时间窗: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
To describe the clinical course of patients treated with Uptravi.
次要结局
未报告次要终点