A Registry for Patients Taking Uptravi (SPHERE)

• ClinicalTrials.gov Identifier: NCT03278002
• Recruitment Status: Completed
• First Posted: September 11, 2017
• Last Update Posted: October 27, 2021
• Sponsor: Actelion
• Information provided by (Responsible Party): Actelion

Tracking Information

• First Submitted Date: August 29, 2017
• First Posted Date: September 11, 2017
• Last Update Posted Date: October 27, 2021
• Actual Study Start Date: November 1, 2016
• Actual Primary Completion Date: September 21, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2017)

• 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.

Original Primary Outcome Measures (submitted: September 6, 2017)

• Using Electronic Medical Records, the change in Hemodynamics (by RHC), WHO FC and 6MWD 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, dose at selected interval, highest dose, maintenance dose, time between titrations, time from initiation to maintenance dose and total duration of exposure to Uptravi 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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Registry for Patients Taking Uptravi
• Official Title: Uptravi® (SelexiPag): tHe usErs dRug rEgistry
• 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.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 18 Months
• Biospecimen: Not Provided
• 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.
• Condition: Pulmonary Arterial Hypertension
• Intervention: Not Provided

Study Groups/Cohorts

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.

• 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 6, 2018): 800
• Original Estimated Enrollment (submitted: September 6, 2017): 500
• Actual Study Completion Date: September 21, 2021
• Actual Primary Completion Date: September 21, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT03278002
• Other Study ID Numbers: AC-065A402
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Actelion
• Original Responsible Party: Same as current
• Current Study Sponsor: Actelion
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Actelion; Actelion

• PRS Account: Actelion
• Verification Date: October 2021