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A Registry for Patients Taking Uptravi (SPHERE)

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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

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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

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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
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Contact: Study Lead 1-800-540-5687 MEH@actelion.com

  Show 70 Study Locations
Sponsors and Collaborators
Actelion

Additional Information:

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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

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