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Open-label, Single-arm, Non-controlled Trial to Evaluate Safety and Tolerability of Treprostinil Sodium in Children Below the Age of 18 Years Diagnosed With Pulmonary Arterial Hypertension (PAH)
The goal of this clinical trial is to evaluate safety and tolerability of preservative-free parenteral treprostinil in paediatric patients with PAH (PH Group 1) who are below 18 years of age. The main question it aims to answer is: • if preservative-free parenteral treprostinil is safe and tolerable in the treatment of paediatric PAH in patients who are either prostacyclin-naïve or have been previously treated with commercially available parenteral treprostinil formulations. Participants will receive either subcutaneous (SC) or intravenous (IV) preservative-free treprostinil and will be observed for 5 months (20 weeks ± 1 week).
Details
| Lead sponsor | AOP Orphan Pharmaceuticals AG |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 20 |
| Start date | 2024-07-31 |
| Completion | 2028-11 |
Conditions
- Pulmonary Arterial Hypertension
Interventions
- preservative-free parenteral treprostinil
Primary outcomes
- Frequency and seriousness of adverse events and adverse drug reactions — 5 months (20 weeks ± 1 weeks)
The frequency and seriousness of adverse events and adverse drug reactions during the first 5 months (20 weeks ± 1 weeks) of treatment according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Countries
Austria, France, Hungary, Slovakia, Spain