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

Pulmonary Arterial Hypertension Clinical Trial

Official title:
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)

Clinical Trial 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).

Clinical Trial Description

In this study, a preservative-free treprostinil solution provided in a single-use vial will be used. Efficacy of treprostinil for the treatment of PAH in pulmonary hypertension (PH) Group 1 in children is reported throughout literature. However, since the removal of the preservative might impact the safe use of the parenteral solution for infusion, the safety profile of the newly developed preservative-free treprostinil solution will be assessed within this trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06350032
Study type Interventional
Source AOP Orphan Pharmaceuticals AG
Contact Clinical Project Manager
Phone 4366488375206
Email trepaed@aop-health.com
Status Not yet recruiting
Phase Phase 3
Start date May 2024
Completion date November 2028
View Details
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