Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05976217 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis
A Early Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT05976217 is a Early Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 3 participants.
The verdict
NCT05976217, a Early Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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.
Interventions
- DRUG Venetoclax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2024-03-20 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05976217
The ClinicalTrials.gov registry entry for NCT05976217 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Venetoclax is the first listed.
NCT05976217 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05976217 about?
NCT05976217 is a clinical study titled "Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis". 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. I...
What is the current status of trial NCT05976217?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2023-10-01. Estimated completion is 2024-03-20.
What interventions are being tested in trial NCT05976217?
The interventions under investigation include: Venetoclax (DRUG).
Who is sponsoring clinical trial NCT05976217?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.