Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05557942
Status:
TERMINATED
Last Update Posted:
2024-06-21
First Post:
2022-09-15
Brief Title:
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension IMPAHCT-FUL
Sponsor:
Aerovate Therapeutics
Organization:
Aerovate Therapeutics
Study Overview
Official Title:
A Long-Term Extension Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension PAH Who Have Completed Study AV-101-002 IMPAHCT-FUL
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results from the parent study IMPAHCT demonstrated that while inhaled imatinib was well tolerated it did not prove to be efficacious at any of the doses of AV-101 evaluated in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPAHCT-FUL
Brief Summary:
IMPAHCT-FUL Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension LTE Trial was a follow up study to establish the long-term safety of AV-101 Subjects who successfully completed the 24-week placebo-controlled parent trial AV-101-002 NCT05036135 were offered the opportunity to continue into this LTE study Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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