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

This is a prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of oral treprostinil. Patients newly initiated on oral treprostinil for the treatment of pulmonary arterial hypertension or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe:

• Oral treprostinil dosing
• Prostacyclin-related adverse events
  
• Health-related quality of life
  
• Clinical outcomes

Key inclusion criteria:

• Patient is newly prescribed or has been receiving oral treprostinil for ≤21 days
• Patient has access to the internet and is willing to complete on-line survey

Key exclusion criteria:

• Patient is currently participating in an investigational study

Clinic responsibilities:

• Enrollment of patients via paper informed consent form and online ProPortal registration
• Records patients’ normal standard of care assessments (up to 6 visits)
  • No study-specific visits, interventional procedures, or laboratory tests

Patient responsibilities:

• Record oral treprostinil usage and tolerability through an online portal, as well as:
  • Prostacyclin-related adverse events and treatment
  • Quality-of-life surveys and health improvements
• Attend standard-of-care visits for route monitoring

Target enrollment is 300 patients.

For questions, email ADAPT@unither.com.