← Back to Search

BH3 Mimetic

Venetoclax for Idiopathic Pulmonary Fibrosis

Phase < 1
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of IPF that fulfills current ATS/ERS Consensus Criteria (1)
Age between 40-85 years old, male and female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Study Summary

This trial suggests a new therapy for IPF based on targeting a mitochondrial protein, Bcl-2, to induce apoptosis of macrophages and reduce fibrosis. ABT-199, a Bcl-2 inhibitor, has been shown effective in preclinical and clinical trials in another disease.

Who is the study for?
This trial is for adults aged 40-85 with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) that's been known for less than 5 years and have at least moderate lung function. Participants must be able to consent, follow the study plan, and not be on certain other drugs or have major health issues like severe liver problems, heart conditions, recent infections, kidney disease requiring dialysis, or a history of cancer in the last 5 years.Check my eligibility
What is being tested?
The trial tests Venetoclax's safety and effectiveness in treating IPF. Researchers believe it may help by causing problematic cells in the lungs to self-destruct. The drug has worked well before in leukemia patients without serious side effects.See study design
What are the potential side effects?
Venetoclax could potentially cause side effects such as digestive issues, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. It might also affect liver enzymes and interact with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with idiopathic pulmonary fibrosis.
Select...
I am between 40 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by measuring blood counts.
Number of participants with treatment-related adverse events as assessed by measuring liver function.
Secondary outcome measures
Percentage of monocyte-derived macrophages that undergoing apoptosis.

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Hypokalaemia
11%
Dermatitis
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment1 Intervention
Venetoclax 100 mg daily for 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,041 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
1,199 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Venetoclax (BH3 Mimetic) Clinical Trial Eligibility Overview. Trial Name: NCT05976217 — Phase < 1
Idiopathic Pulmonary Fibrosis Research Study Groups: treatment
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT05976217 — Phase < 1
Venetoclax (BH3 Mimetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05976217 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals still sign up for this research project?

"As stated on clinicaltrials.gov this trial has concluded its recruitment phase; the initial posting was dated September 1st 2023 and the last update occurred August 3rd 2023. However, there are currently 419 other studies actively recruiting participants at this time."

Answered by AI

Who is eligible to partake in this research trial?

"This medical study is recruiting approximately 5 individuals with idiopathic pulmonary fibrosis and aged between 40 to 85. Those who meet the inclusion criteria will have the opportunity to partake in this trial."

Answered by AI

Are individuals of all ages eligible for participation in this research study?

"The age criteria for enrolment in this study dictates that all participants must be between 40 and 85 years old."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
A. Brent Carter
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis
A. Brent Carter, MD 2023. "Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05976217.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top