Status:
COMPLETED
Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-85 years
Phase:
EARLY_PHASE1
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). Sp...
Eligibility Criteria
Inclusion
- Age between 40-85 years old, male and female.
- A diagnosis of IPF that fulfills current ATS/ERS Consensus Criteria (1).
- IPF duration \<5 years, based on the date of definitive diagnosis.
- Ability and willingness to give informed consent and adhere to study requirements.
- Forced Vital Capacity (FVC) \> 50% predicted values.
Exclusion
- Diagnosis of major comorbidities expected to interfere with study participation.
- History of malignancy within the last 5 years, excluding basal or squamous cell skin cancer.
- The occurrence of any acute infection requiring systemic antibiotic therapy within 2 weeks prior to Screening (Visit 1).
- Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, azathioprine, etc.), given increased risks of opportunistic infections.
- Concurrent participation in other experimental trials.
- Fertile women who do not agree to abstinence or an effective form of contraception (as approved by the investigator), or who are breast feeding, for 4 weeks before randomization until 90 days after the last administration of study medication (or placebo).
- Men who are not surgically sterile and do not agree to remain abstinent from heterosexual intercourse or use effective contraception (as approved by the investigator), and refrain from donating sperm, from the time of giving informed consent until 90 days after the last administration of study medication (or placebo).
- Subjects with known hypersensitivity to capsule "bulking" agents.
- A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin \< 10.0 g/dL (or 6.2 mmol/L).
- Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, congestive heart failure (NYHA Class III or IV), or stroke, including a transient ischemic attack.
- 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).
- End-stage renal disease requiring dialysis.
- Undergoing transplantation evaluation or listed with the United Network for Organ Sharing (UNOS) as a lung transplantation candidate at the time of enrollment in this trial.
- Liver function tests (transaminases, alkaline phosphatase, direct and total bilirubin) \>2x upper limit of normal values.
- Systemically administered potent CYP3A4 inhibitors or inducers are prohibited during the 24-week treatment period.
- Inhibitors include: pirfenidone, boceprevir, cobicistat, conivaptan, ritonavir, itraconazole, ketoconazole, telaprevir, troleandomycin, voriconazole, clarithromycin, diltiazem, idelalisib, nefazodone, nelfinavir.
- Inducers include: carbamazepine, enzalutamide, mitotane, phenytoin, rifampin.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05976217
Start Date
October 1 2023
End Date
March 20 2024
Last Update
March 28 2024
Active Locations (2)
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1
TKC
Birmingham, Alabama, United States, 35214
2
UAB
Birmingham, Alabama, United States, 35233