Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03278002
Previous Study | Return to List | Next Study

A Registry for Patients Taking Uptravi (SPHERE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278002
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

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.

Condition or disease
Pulmonary Arterial Hypertension

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
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


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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278002


Contacts
Layout table for location contacts
Contact: Study Lead 1-800-540-5687 MEH@actelion.com

  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
University of Arizona-Clinical Translational and Regenerative Medicine Recruiting
Tucson, Arizona, United States, 85724
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
University of Southern California Recruiting
Los Angeles, California, United States, 90033
VA Greater Los Angeles Healthcare Center Recruiting
Los Angeles, California, United States, 90073
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
LA Biomed Research Inst at Harbor UCLA Medical Center Recruiting
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Banner Health Research Institute Recruiting
Greeley, Colorado, United States, 80631
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
University of Florida-Jacksonville College of Medicine Recruiting
Jacksonville, Florida, United States, 32209
Central Florida Pulmonary Group Recruiting
Orlando, Florida, United States, 32803
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Wellstar Marietta Pulmonary Medicine Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
University of Chicago Hospitals Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
St. Vincent Medical Group, Inc. Recruiting
Indianapolis, Indiana, United States, 46260
United States, Iowa
CIC Associates Recruiting
Clive, Iowa, United States, 50325
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Medical Foundation Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maine
Chest Medicine Associates Recruiting
South Portland, Maine, United States, 4106
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 2111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 2114
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
William Beaumont Hospital Recruiting
Troy, Michigan, United States, 48085
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Somnos Clinical Research Recruiting
Lincoln, Nebraska, United States, 68510
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 7112
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Northwell Health Recruiting
New Hyde Park, New York, United States, 11040
Weil Cornell Medicine Recruiting
New York, New York, United States, 10065
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina Hospitals at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
The Lindner Research Center Recruiting
Cincinnati, Ohio, United States, 45219
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Southwest General Health Center Recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oregon
Legacy Medical Group-Pulmonary and Sleep Clinic Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Doylestown Cardiology Associates-VIAA Recruiting
Doylestown, Pennsylvania, United States, 18901
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
York Hospital Recruiting
York, Pennsylvania, United States, 17402
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 2903
United States, South Carolina
AnMed Health Medical Center Recruiting
Anderson, South Carolina, United States, 29621
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Scott and White Health Recruiting
Dallas, Texas, United States, 75246
University of Texas, Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
University of Texas, Houston Health Center Recruiting
Houston, Texas, United States, 77030
Methodist Healthcare of San Antonio Recruiting
Sam Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia System Recruiting
Charlottesville, Virginia, United States, 22908
Inova Heart and Vascular Institute Recruiting
Falls Church, Virginia, United States, 22042
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
United States, Wisconsin
University of Wisconsin Hospital Recruiting
Madison, Wisconsin, United States, 53705
Froedtert Hospital & Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53150
Aurora Research Institute, LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Puerto Rico
Allianze Medical Services, CardioPulmonary Research Group Recruiting
Guaynabo, Puerto Rico, 917
Sponsors and Collaborators
Actelion

Additional Information:

Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03278002     History of Changes
Other Study ID Numbers: AC-065A402
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Selexipag
Antihypertensive Agents