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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: Completed Early Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT05976217 is a Early Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
complete metabolic panel
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 |
What the finished NCT05976217 record still lists
NCT05976217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Venetoclax is the first listed.
NCT05976217 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05976217's enrollment target sits among peer trials
3 1949th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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