Pulmonary Arterial HypertensionSPHERENCT03278002
A Registry for Patients Taking Uptravi
An observational study of Pulmonary Arterial Hypertension, run by Actelion at 85 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 800 participants
- Where
- 85 sitesin 2 countries
- Study dates
- 1 Nov 2016to 21 Sep 2021
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
85 sites in 2 countries.
85 sites in 2 countries
United States84 sites
University of New Mexico
Albuquerque, New Mexico, 87131
AnMed Health Medical Center
Anderson, South Carolina, 29621
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Tufts University Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Florida Lung Asthma and Sleep Specialists
Celebration, Florida, 34747
University of North Carolina Hospitals at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Chicago Hospitals
Chicago, Illinois, 60637
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
CIC Associates
Clive, Iowa, 50325
Baylor Scott and White Health
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax
Falls Church, Virginia, 22042
Pulmonary Health Physicians, PC
Fayetteville, New York, 13066
Broward Pulmonary and Sleep
Fort Lauderdale, Florida, 33316
University of Florida, HSC
Gainesville, Florida, 32610
Banner Health Research Institute
Greeley, Colorado, 80631
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas, Houston Health Center
Houston, Texas, 77030
West Pasco Pulmonary Associates
Hudson, Florida, 34667
Indiana University Health
Indianapolis, Indiana, 46202
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Florida-Jacksonville College of Medicine
Jacksonville, Florida, 32209
University of California San Diego
La Jolla, California, 92093
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Somnos Clinical Research
Lincoln, Nebraska, 68510
University of Southern California
Los Angeles, California, 90033
VA Greater Los Angeles Healthcare Center
Los Angeles, California, 90073
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
Wellstar Marietta Pulmonary Medicine
Marietta, Georgia, 30060
Southwest General Health Center
Middleburg Heights, Ohio, 44130
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53150
Aurora Research Institute / Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Winthrop University Hospital
Mineola, New York, 11501
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
University of South Alabama
Mobile, Alabama, 36617
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Northwell Health
New Hyde Park, New York, 11040
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Oschner Clinic Foundation/Oschner Medical Center
New Orleans, Louisiana, 70121
Mount Sinai Hospital
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Weil Cornell Medicine
New York, New York, 10065
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Central Florida Pulmonary Group
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Pulmonary Associates
Phoenix, Arizona, 85006
Cardioivascular Consultants, Ltd.
Phoenix, Arizona, 85027
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Legacy Medical Group-Pulmonary and Sleep Clinic
Portland, Oregon, 97210
Oregon Health & Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Methodist Healthcare of San Antonio
San Antonio, Texas, 78229
UCSF Medical Center
San Francisco, California, 94143
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Chest Medicine Associates
South Portland, Maine, 04106
Providence Health & Services d/b/a/ Providence Sacred Heart Medical Center & Children's Hospital Providence Medical Research Center
Spokane, Washington, 99204
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Research, Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Stony Brook University Medical Center
Stony Brook, New York, 11794
Multicare Institute for Research & Innovation
Tacoma, Washington, 98405
University of South Florida
Tampa, Florida, 33606
Lundquist Institute for Biomedical Innovation at Harbor-UCLA
Torrance, California, 90502
William Beaumont Hospital
Troy, Michigan, 48085
University of Arizona-Clinical Translational and Regenerative Medicine
Tucson, Arizona, 85724
Cleveland Clinic Florida
Weston, Florida, 33331
York Hospital
York, Pennsylvania, 17402
About this study
Official title: 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.
- Conditions
- Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
To describe the clinical course of patients treated with Uptravi.
Measured: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Nov 2016
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Actelion, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278002
- Sponsor's protocol ID
- AC-065A402
- Acronym
- SPHERE
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2017
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33526303
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uptravi® (SelexiPag): tHe usErs dRug rEgistry
- ClinicalTrials.gov ID
- NCT03278002
- Acronym / sponsor ID
- SPHERE / AC-065A402
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Signed patient informed consent form (ICF).
- Patients ≥ 18 years of age at time of Uptravi initiation, and
- Patients who initiate Uptravi:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 33526303Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Actelion study director
Actelion
85 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Actelion at 85 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Followed prospectively for a maximum of 18 months from the date of enrollment into the registry.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.