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Study identifier: NCT06350032 Synced from ClinicalTrials.gov · August 03, 2026
● Recruiting

Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH

Condition: Pulmonary Arterial Hypertension  ·  Sponsor: AOP Orphan Pharmaceuticals AG

PhasePhase 3
Planned participants20
Who can joinAll sexes, N/A to 18 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Project Manager  ·  4366488375206  ·  trepaed@aop-health.com

Always discuss trial participation with your own doctor first.

Locations (5)

Medizinische Universität WienVienna, State of Vienna, AustriaRecruiting
Necker-Enfants Malades Hospital, ParisParis, Paris, FranceRecruiting
Gottsegen National Cardiovascular CenterBudapest, Budapest, HungaryRecruiting
Pediatric Cardiac CenterBratislava, SlovakiaRecruiting
Ramón y Cajal University HospitalMadrid, Madrid, SpainRecruiting

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