A Registry for Patients Taking Uptravi

Pulmonary Arterial Hypertension Clinical Trial

— SPHERE  

Official title:

Uptravi® (SelexiPag): tHe usErs dRug rEgistry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278002
• Other study ID #: AC-065A402
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: September 21, 2021

Study information

• Verified date: October 2021
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Locations

Country	Name	City	State
Puerto Rico	CardioPulmonary Research, PSC	Guaynabo
United States	University of New Mexico	Albuquerque	New Mexico
United States	AnMed Health Medical Center	Anderson	South Carolina
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	University of Maryland	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts University Medical Center	Boston	Massachusetts
United States	Florida Lung Asthma and Sleep Specialists	Celebration	Florida
United States	University of North Carolina Hospitals at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Chicago Hospitals	Chicago	Illinois
United States	The Lindner Research Center at The Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	CIC Associates	Clive	Iowa
United States	Baylor Scott and White Health	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Doylestown Health Cardiology	Doylestown	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax	Falls Church	Virginia
United States	Pulmonary Health Physicians, PC	Fayetteville	New York
United States	Broward Pulmonary and Sleep	Fort Lauderdale	Florida
United States	University of Florida, HSC	Gainesville	Florida
United States	Banner Health Research Institute	Greeley	Colorado
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Texas, Houston Health Center	Houston	Texas
United States	West Pasco Pulmonary Associates	Hudson	Florida
United States	Indiana University Health	Indianapolis	Indiana
United States	St. Vincent Medical Group, Inc.	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Florida-Jacksonville College of Medicine	Jacksonville	Florida
United States	University of California San Diego	La Jolla	California
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Somnos Clinical Research	Lincoln	Nebraska
United States	University of Southern California	Los Angeles	California
United States	VA Greater Los Angeles Healthcare Center	Los Angeles	California
United States	Norton Pulmonary Specialists	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Wellstar Marietta Pulmonary Medicine	Marietta	Georgia
United States	Southwest General Health Center	Middleburg Heights	Ohio
United States	Aurora Research Institute / Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin/Froedtert Hospital	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	University of South Alabama	Mobile	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Northwell Health	New Hyde Park	New York
United States	LSU Health Sciences Center	New Orleans	Louisiana
United States	Oschner Clinic Foundation/Oschner Medical Center	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Weil Cornell Medicine	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Central Florida Pulmonary Group	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Cardioivascular Consultants, Ltd.	Phoenix	Arizona
United States	Pulmonary Associates	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Legacy Medical Group-Pulmonary and Sleep Clinic	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mercy Research, Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Methodist Healthcare of San Antonio	San Antonio	Texas
United States	UCSF Medical Center	San Francisco	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Chest Medicine Associates	South Portland	Maine
United States	Providence Health & Services d/b/a/ Providence Sacred Heart Medical Center & Children's Hospital Providence Medical Research Center	Spokane	Washington
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Multicare Institute for Research & Innovation	Tacoma	Washington
United States	University of South Florida	Tampa	Florida
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA	Torrance	California
United States	William Beaumont Hospital	Troy	Michigan
United States	University of Arizona-Clinical Translational and Regenerative Medicine	Tucson	Arizona
United States	Cleveland Clinic Florida	Weston	Florida
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.