Clinical trial NCT03278002: A Registry for Patients Taking Uptravi
Official title: Uptravi® (SelexiPag): tHe usErs dRug rEgistry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2017-09-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The number of patients planned to be enrolled in the study is approximately 800 patients from approximately 80 centers in the U.S.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
measure: 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.
timeFrame: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
measure: Occurrence of AEs and SAEs (incl. hospitalizations), discontinuation of Uptravi and reason for stopping and occurrence of all-cause death by relationship to PAH.
timeFrame: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Phoenix
country: United States
facility: Cardioivascular Consultants, Ltd.
state: Arizona
city: Tucson
country: United States
facility: University of Arizona-Clinical Translational and Regenerative Medicine
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Greeley
country: United States
facility: Banner Health Research Institute
state: Colorado
city: Celebration
country: United States
facility: Florida Lung Asthma and Sleep Specialists
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Pulmonary and Sleep
state: Florida
city: Gainesville
country: United States
facility: University of Florida, HSC
state: Florida
city: Hudson
country: United States
facility: West Pasco Pulmonary Associates
state: Florida
city: Jacksonville
country: United States
facility: University of Florida-Jacksonville College of Medicine
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Marietta
country: United States
facility: Wellstar Marietta Pulmonary Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc.
state: Indiana
city: Clive
country: United States
facility: CIC Associates
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Norton Pulmonary Specialists
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Oschner Clinic Foundation/Oschner Medical Center
state: Louisiana
city: South Portland
country: United States
facility: Chest Medicine Associates
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Research, Mercy Hospital Saint Louis
state: Missouri
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Fayetteville
country: United States
facility: Pulmonary Health Physicians, PC
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weil Cornell Medicine
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center at The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest General Health Center
state: Ohio
city: Portland
country: United States
facility: Legacy Medical Group-Pulmonary and Sleep Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Health Cardiology
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott and White Health
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas, Houston Health Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare of San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Spokane
country: United States
facility: Providence Health & Services d/b/a/ Providence Sacred Heart Medical Center & Children's Hospital Providence Medical Research Center
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute for Research & Innovation
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Research Institute / Aurora St. Luke's Medical Center
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: CardioPulmonary Research, PSC
Study officials:
affiliation: Actelion
name: Actelion
role: STUDY_DIRECTOR
References:
citation: Kim NH, Hemnes AR, Chakinala MM, Highland KB, Chin KM, McLaughlin V, Zhao C, Narayan V, Farber HW. Patient and disease characteristics of the first 500 patients with pulmonary arterial hypertension treated with selexipag in real-world settings from SPHERE. J Heart Lung Transplant. 2021 Apr;40(4):279-288. doi: 10.1016/j.healun.2021.01.006. Epub 2021 Jan 15.