Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06274801
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-01-19
Brief Title:
Open-label Extension Study of Seralutinib in Adult Subjects With PAH PROSERA-EXT
Sponsor:
GB002 Inc
Organization:
Gossamer Bio Inc
Study Overview
Official Title:
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension PAH
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This open-label extension study will evaluate the long-term safety tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
Detailed Description:
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
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 |
|---|---|---|---|
| 2023-506334-75 | EUDRACT_NUMBER | None | None |