Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976217
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-07-26
Brief Title:
Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Based on preclinical data investigators hypothesize that apoptosis resistance in monocyte-derived macrophages MDMs have a decisive role in the development of idiopathic pulmonary fibrosis IPF Specifically macrophages from subjects with IPF have increased expression of Bcl-2 in mitochondria In preclinical models of IPF a conditional deletion of Bcl-2 in MDMs reverses established fibrosis by inducing apoptosis Additional evidence to suggest that Bcl-2 expression in MDM mitochondria is a therapeutic target for IPF as administration of the Bcl-2 inhibitor ABT-199 Venetoclax showed marked efficacy in preclinical models of IPF by inducing apoptosis of MDMs and reversing established fibrosis ABT-199 is an orally available mimetic of the BH3 domain of Bcl-2 which is the domain the anchors Bcl-2 in the mitochondria to inhibit apoptosis ABT-199 has shown therapeutic efficacy and good safety and tolerability in patients with chronic lymphocytic leukemia Investigators anticipate that treatment with ABT-199 could result in significant benefit for IPF patients that have a life expectancy of 3-5 years As there is no curative therapy for IPF this clinical trial has the potential to substantially alter treatment approaches in patients with IPF
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?:
False
Is an FDA AA801 Violation?:
None