ADAPT - A Patient Registry of the Real-world Use of Orenitram®

Study Overview
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Brief Summary
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This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation

Official Title
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ADAPT - A Patient Registry of the Real-world Use of Orenitram®

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Oral treprostinil


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Patients are eligible for the registry if: The patient voluntarily gives informed consent to participate in the study. The patient must be at least 18 years of age or older. The patient is prescribed Orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving Orenitram for 182 or fewer days. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study. The patient has the ability to answer surveys and use the diary in English. The patient must have an email address and be willing to access the PRO Portal. EXCLUSION CRITERIA Patients are ineligible for the registry if: The patient has previously received Orenitram for more than 182 days. The patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than Orenitram in PAH within

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral treprostinil<br>Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients | Drug: Oral treprostinil<br>* Sustained-release oral tablets for TID administration<br>* Other names: Treprostinil diolamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients |  | Baseline to Week 78 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess treatment-related outcomes during routine clinical care. | eg, 6-Minute Walk Distance [6MWD], World Health Organization [WHO] Functional Class [FC] | Baseline to Week 78 | 
| To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest |  | Baseline to Week 78 | 
| Use of concomitant medications |  | Baseline to Week 78 | 
| To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies |  | Baseline to Week 78 | 
| Healthcare resource utilization trends |  | Baseline to Week 78 | 
| Health-related quality of life in PAH and treatment satisfaction |  | Baseline to Week 78 | 
| To evaluate reasons for discontinuation of Orenitram |  | Baseline to Week 78 | 
| To evaluate titration and dosing schedules of Orenitram |  | Baseline to Week 78 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAH, Oral Treprostiinil, Orenitram