A Registry for Patients Taking Uptravi

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CardioPulmonary Research, PSC, Guaynabo, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

Uptravi® (SelexiPag): tHe usErs dRug rEgistry

Acronym: SPHERE

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Sep 11, 2017
Registry last updated: Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed