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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 4 to 5v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to Jul 31, 2024
    • Site details revised at 4 of 4 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06350032
Lead Sponsor AOP Orphan Pharmaceuticals AG
Conditions
(from sponsor)		 Pulmonary Arterial Hypertension
Related terms Pulmonary Arterial Hypertension
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov