A Registry for Patients Taking Uptravi

Study Overview
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Brief Summary
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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.

Official Title
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Uptravi® (SelexiPag): tHe usErs dRug rEgistry

Conditions
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Pulmonary Arterial Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group/Cohort Information<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | To describe demographics and disease characteristics of patients treated with Uptravi. | Followed prospectively for a maximum of 18 months from the date of enrollment into the registry. | 
| 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. | 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. | Followed prospectively for a maximum of 18 months from the date of enrollment into the registry. | 
| Occurrence of AEs and SAEs (incl. hospitalizations), discontinuation of Uptravi and reason for stopping and occurrence of all-cause death by relationship to PAH. | To describe the clinical course of patients treated with Uptravi. | Followed prospectively for a maximum of 18 months from the date of enrollment into the registry. |