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NCT06350032Not yet recruiting

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

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)
AOP Orphan Pharmaceuticals AGPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
preservative-free parenteral treprostinil
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AOP Orphan Pharmaceuticals AG
Location
Vienna,Paris,Budapest,Madrid, Austria,France,Hungary,Spain
Timeline & enrollment
Phase
Phase 3
Start date
May 01, 2024
End date
Nov 01, 2028
Enrollment
20 participants
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
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06350032
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.