Pulmonary Arterial Hypertension
Conditions
Keywords
PAH, Oral Treprostiinil, Orenitram
Brief summary
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
Interventions
Sustained-release oral tablets for TID administration
Sponsors
United Therapeutics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible for the registry if: 1. The patient voluntarily gives informed consent to participate in the study. 2. The patient must be at least 18 years of age or older. 3. 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. 4. 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. 5. The patient has the ability to answer surveys and use the diary in English. 6. The patient must have an email address and be willing to access the PRO Portal.
Exclusion criteria
Patients are ineligible for the registry if: 1. The patient has previously received Orenitram for more than 182 days. 2. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients | Baseline to Week 78 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess treatment-related outcomes during routine clinical care. | Baseline to Week 78 | eg, 6-Minute Walk Distance \[6MWD\], World Health Organization \[WHO\] Functional Class \[FC\] |
| 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 | — |
Countries
United States
Outcome results
None listed