A Registry for Patients Taking Uptravi (SPHERE)
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ClinicalTrials.gov Identifier: NCT03278002 |
Recruitment Status :
Completed
First Posted : September 11, 2017
Last Update Posted : October 27, 2021
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Condition or disease |
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Pulmonary Arterial Hypertension |
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 |
Actual Primary Completion Date : | September 21, 2021 |
Actual Study Completion Date : | September 21, 2021 |
Group/Cohort |
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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.
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- 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.
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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 |
Inclusion Criteria:
- Signed patient informed consent form (ICF).
- Patients ≥ 18 years of age at time of Uptravi initiation, and
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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.
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
Study Director: | Actelion | Actelion |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT03278002 |
Other Study ID Numbers: |
AC-065A402 |
First Posted: | September 11, 2017 Key Record Dates |
Last Update Posted: | October 27, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |