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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
Must not have
Evidence of cardiac conducting abnormalities, defined as second- or third-degree AV block not successfully treated with a pacemaker, or a personal or family history of long QT syndrome (QTc interval >450 msec for males or 470 msec for females)
A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin < 10.0 g/dL (or 6.2 mmol/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing ABT-199, a drug that helps certain immune cells die, in patients with idiopathic pulmonary fibrosis (IPF). IPF is a serious lung disease with no cure. The drug works by blocking a protein that prevents cell death, potentially reducing lung damage. This could offer significant benefits for IPF patients. ABT-199 has shown promise in reducing lung inflammation and fibrosis in animal models of pulmonary fibrosis.
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.
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.
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 belowSelect...
I have been diagnosed with idiopathic pulmonary fibrosis.
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I am between 40 and 85 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have untreated heart rhythm problems or a family history of long QT syndrome.
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I have a history of severe anemia or bone marrow disorders.
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I haven't taken high-dose steroids or immunosuppressants in the last month.
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I haven't needed antibiotics for an infection in the last 2 weeks.
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I am not taking strong drugs that affect liver enzyme activity during my treatment.
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I am on dialysis for end-stage kidney disease.
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I haven't had cancer in the last 5 years, except for skin cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Percentage of monocyte-derived macrophages that undergoing apoptosis.
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2200
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib and pirfenidone, which work by slowing disease progression and reducing acute exacerbations. Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factors involved in fibrosis, inhibiting fibroblast proliferation and collagen deposition.
Pirfenidone has antifibrotic and anti-inflammatory properties, reducing fibroblast activity and collagen synthesis. Additionally, ABT-199 (Venetoclax) is being studied for its ability to induce apoptosis in monocyte-derived macrophages (MDMs) by inhibiting Bcl-2, a protein that prevents cell death.
This mechanism is significant as it targets the cellular components contributing to fibrosis, potentially reversing established fibrosis. Understanding these mechanisms is crucial for IPF patients as it highlights the therapeutic strategies aimed at slowing disease progression and improving survival.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,632 Previous Clinical Trials
2,304,976 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
1,199 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can breathe out a lot of air compared to what is expected for someone your size.I am a man who agrees to use contraception or remain abstinent and not donate sperm during and 90 days after the study.I have not had a severe heart issue or stroke in the last 3 months.I do not have untreated heart rhythm problems or a family history of long QT syndrome.I have been diagnosed with idiopathic pulmonary fibrosis.I have a history of severe anemia or bone marrow disorders.I haven't taken high-dose steroids or immunosuppressants in the last month.I haven't needed antibiotics for an infection in the last 2 weeks.I am not taking strong drugs that affect liver enzyme activity during my treatment.Your liver function tests show levels of certain chemicals that are more than twice the normal amount.I am on dialysis for end-stage kidney disease.I am between 40 and 85 years old.My IPF was diagnosed less than 5 years ago.You are allergic to the materials used in the study capsules.You are being considered for a lung transplant or are on the waiting list for a lung transplant.I haven't had cancer in the last 5 years, except for skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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