Thromboxane-Prostanoid Receptor Signaling Drives Persistent Fibroblast Activation in Pulmonary Fibrosis.
Toshio Suzuki, Jonathan A Kropski, Jingyuan Chen...
https://pubmed.ncbi.nlm.nih.gov/35728047Actively Recruiting
Phase 2
Age: 40Years +
All Genders
ID05571059
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Determine the Safety and Efficacy of Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Led by Cumberland Pharmaceuticals · Updated on 2026-03-05
128
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of oral ifetroban in patients with idiopathic pulmonary fibrosis (IPF), a condition that causes lung scarring from various causes such as genetics, radiation, or bleomycin treatment. This phase II, multicenter, randomized, placebo-controlled study compares ifetroban to a placebo in adults aged 40 years and older who have confirmed IPF. The study aims to assess ifetroban's ability to prevent and treat lung fibrosis over a 12-month period. Participants will be randomly assigned to receive either 250 mg of oral ifetroban or a matching placebo capsule once daily for 12 months. Patients may continue stable background therapy with antifibrotic agents if applicable. The study includes two groups: one receiving ifetroban and the other receiving placebo, with treatments administered daily. Blood and urine samples will be collected to measure both standard and novel biomarkers related to progressive pulmonary fibrosis. Throughout the study, participants will undergo safety and efficacy assessments including lung function tests, quality of life questionnaires, and monitoring for adverse events. Researchers will measure changes in forced vital capacity (FVC) over 12 months as the primary outcome. Secondary outcomes include time to acute exacerbations, hospitalizations, death, and symptom changes such as dyspnea, cough, and fatigue. Participants' health will be regularly monitored via clinical evaluations and laboratory tests to ensure safety and track treatment effects.
CONDITIONS
Brief Title
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female age 40 years or older
- Confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) based on 2022 ATS/ERS/JRS/ALAT criteria
- Usual interstitial pneumonia (UIP) or probable UIP pattern on chest HRCT within 2 months or historical lung biopsy consistent with UIP
- Stable dose of antifibrotic agents pirfenidone or nintedanib for at least 2 months prior to Day 0 if used, or naive/not on these drugs for at least 4 weeks
- Stable monotherapy treatment for pulmonary hypertension for at least 4 weeks prior to Day 0 if applicable
- Forced vital capacity (FVC) at least 40% of predicted normal
- Diffusion capacity of carbon monoxide (DLCO) corrected for hemoglobin between 25% and less than 80% of predicted normal
You will not qualify if you...
- Airway obstruction with FEV1/FVC ratio less than 0.7
- Other clinically significant pulmonary abnormalities as determined by investigator
- Significant pulmonary arterial hypertension requiring combination or parenteral therapy
- Emphysema greater than or equal to 50% on HRCT or more extensive than fibrosis
- Acute IPF exacerbation within 6 weeks prior to screening or during screening
- Interstitial lung disease due to other known causes
- Recent lower respiratory tract infection requiring antibiotics within 4 weeks prior to Day 0 or during screening
- Major surgery within 6 weeks prior to Day 0 or planned during trial (except transplant list status)
- Elevated liver enzymes or impaired kidney function (AST/ALT >1.5 x ULN, Bilirubin >1.5 x ULN, Creatinine clearance <30 mL/min)
- Underlying chronic liver disease with any hepatic impairment
- Severe or uncontrolled cardiovascular diseases including hypertension, recent heart attack, or unstable angina
- Known bleeding risk or use of high-dose anticoagulants or antiplatelet therapy
- History of hemorrhagic CNS event within 12 months
- Recent hemoptysis, hematuria, active gastrointestinal bleeding or peptic ulcer disease within 3 months
- Abnormal coagulation parameters (INR >2, prolonged PT/aPTT)
- Thrombotic event within 12 months
- Use of specific immunosuppressive or disease-modifying drugs within 6 months
- Use of systemic corticosteroids equivalent to prednisone >15 mg/day within 2 weeks
- Combination use of pirfenidone and nintedanib at screening
- Other diseases or conditions interfering with trial participation or safety
- Recent or active malignancy within 5 years except select skin or prostate cancers
- Active or suspected infection including recent COVID-19 infection
- Women who are pregnant, nursing, or planning pregnancy during the trial
- Women of childbearing potential not using highly effective birth control
- Active alcohol or drug abuse
- Inability to understand or follow trial procedures including questionnaires without help
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive oral ifetroban or placebo once daily for 12 months to evaluate safety and efficacy for idiopathic pulmonary fibrosis.
Regular visits to assess safety and efficacy during treatment
Trial Site Locations
Total: 19 locations
1
Biosolutions Clinical Research
La Mesa, California, United States, 91942
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
Miami VA Health System
Miami, Florida, United States, 33125
Actively Recruiting
5
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
University of Kansas
Kansas City, Kansas, United States, 66160
Actively Recruiting
8
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
9
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States, 48073
Actively Recruiting
10
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
11
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
12
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
13
Bend Memorial Hospital
Bend, Oregon, United States, 97701
Actively Recruiting
14
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
15
Avera Research Institute
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
16
Pulmonary & Sleep Specialists
Dickson, Tennessee, United States, 37055
Actively Recruiting
17
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
18
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States, 75020
Actively Recruiting
19
UW Health University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
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Research Team
I
Ines Macias-Perez, PhD
I
Ingrid Anderson, PhD, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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