A Registry for Patients Taking Uptravi (SPHERE)
|ClinicalTrials.gov Identifier: NCT03278002|
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : July 8, 2020
|Condition or disease|
|Pulmonary Arterial Hypertension|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||18 Months|
|Official Title:||Uptravi® (SelexiPag): tHe usErs dRug rEgistry|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278002