A Registry for Patients Taking Uptravi (SPHERE)

October 26, 2021 updated by: Actelion

Uptravi® (SelexiPag): tHe usErs dRug rEgistry

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00917
        • CardioPulmonary Research, PSC
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University Of South Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
      • Phoenix, Arizona, United States, 85027
        • Cardioivascular Consultants, Ltd.
      • Tucson, Arizona, United States, 85724
        • University of Arizona-Clinical Translational and Regenerative Medicine
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare Center
      • San Francisco, California, United States, 94143
        • UCSF Medical Center
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
      • Greeley, Colorado, United States, 80631
        • Banner Health Research Institute
    • Florida
      • Celebration, Florida, United States, 34747
        • Florida Lung Asthma and Sleep Specialists
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Pulmonary and Sleep
      • Gainesville, Florida, United States, 32610
        • University of Florida, HSC
      • Hudson, Florida, United States, 34667
        • West Pasco Pulmonary Associates
      • Jacksonville, Florida, United States, 32209
        • University of Florida-Jacksonville College of Medicine
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group
      • Tampa, Florida, United States, 33606
        • University of South Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Marietta, Georgia, United States, 30060
        • Wellstar Marietta Pulmonary Medicine
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Medical Group, Inc.
    • Iowa
      • Clive, Iowa, United States, 50325
        • CIC Associates
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40202
        • Norton Pulmonary Specialists
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center
      • New Orleans, Louisiana, United States, 70121
        • Oschner Clinic Foundation/Oschner Medical Center
    • Maine
      • South Portland, Maine, United States, 04106
        • Chest Medicine Associates
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts University Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63141
        • Mercy Research, Mercy Hospital Saint Louis
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Fayetteville, New York, United States, 13066
        • Pulmonary Health Physicians, PC
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11040
        • Northwell Health
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10065
        • Weil Cornell Medicine
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospitals at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Research Center at The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest General Health Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97210
        • Legacy Medical Group-Pulmonary and Sleep Clinic
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Health Cardiology
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh School of Medicine
      • York, Pennsylvania, United States, 17402
        • York Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Medical Center
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor Scott and White Health
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • University of Texas, Houston Health Center
      • San Antonio, Texas, United States, 78229
        • Methodist Healthcare of San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Health & Services d/b/a/ Providence Sacred Heart Medical Center & Children's Hospital Providence Medical Research Center
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin School of Medicine and Public Health
      • Milwaukee, Wisconsin, United States, 53150
        • Medical College of Wisconsin/Froedtert Hospital
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Research Institute / Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group/Cohort Information
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?

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.
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.
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.
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.
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.
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.
Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Actelion, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

September 21, 2021

Study Completion (ACTUAL)

September 21, 2021

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (ACTUAL)

September 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-065A402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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