Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445673
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-06
First Post:
2024-05-29
Brief Title:
A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension PAH Patients
Sponsor:
AOP Orphan Pharmaceuticals AG
Organization:
AOP Orphan Pharmaceuticals AG
Study Overview
Official Title:
A Prospective Multicenter International Non-interventional Observational Cohort Study to Observe Long-term Treatment Patterns and Real-word Outcomes in PAH Group I Patients Previously Participating in TripleTRE - TripleTRE-NIS
Status:
ENROLLING_BY_INVITATION
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:
TripleTRE-NIS
Brief Summary:
The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study
The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes including disease progression and survival rates in patients who initially participated in and completed the randomized TripleTRE trial
Planned observation duration per patient is a minimum of 3 years
The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes including disease progression and survival rates in patients who initially participated in and completed the randomized TripleTRE trial
Planned observation duration per patient is a minimum of 3 years
Detailed Description:
None
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