Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350032
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-19
Brief Title:
Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
Sponsor:
AOP Orphan Pharmaceuticals AG
Organization:
AOP Orphan Pharmaceuticals AG
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505082-91-00 | CTIS | None | None |