Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH - Trial NCT06350032
Access comprehensive clinical trial information for NCT06350032 through Pure Global AI's free database. This Phase 3 trial is sponsored by AOP Orphan Pharmaceuticals AG and is currently Not yet recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
AOP Orphan Pharmaceuticals AG
Timeline & Enrollment
Phase 3
May 01, 2024
Nov 01, 2028
Primary Outcome
Frequency and seriousness of adverse events and adverse drug reactions
Summary
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 treatment-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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06350032
Non-Device Trial