Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
Recruiting
Phase 3
Interventional Study
Pulmonary Arterial Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- AOP Orphan Pharmaceuticals AG · Industry
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About This Trial
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 prev…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent by the parents or the legal representatives and written assent from appropriately aged participants
2. Males or females from birth to under 18 years of age at the time informed consent was signed
3. Confirmed diagnosis of severe PAH classified as PH Gr…
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