Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04456998
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2020-06-30
Brief Title:
GB002 in Adult Subjects With Pulmonary Arterial Hypertension PAH
Sponsor:
GB002 Inc a wholly owned subsidiary of Gossamer Bio Inc
Organization:
Gossamer Bio Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2023-10
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 primary objective for this trial is to determine the effect of GB002 seralutinib on improving pulmonary hemodynamics in subjects with World Health Organization WHO Group 1 PAH who are Functional Class FC II and III The secondary objective for this trial is to determine the effect of GB002 seralutinib on improving exercise capacity in this population
Detailed Description:
None
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