Actively Recruiting
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Led by Cumberland Pharmaceuticals · Updated on 2026-03-05
128
Participants Needed
19
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic, radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF.
CONDITIONS
Official Title
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 40 years or older
- Diagnosis of idiopathic pulmonary fibrosis (IPF) confirmed by the 2022 ATS/ERS/JRS/ALAT criteria
- Usual interstitial pneumonia (UIP) or probable UIP pattern on chest HRCT within 2 months of Day 0 or historical lung biopsy consistent with UIP
- Stable dose of antifibrotic agents (pirfenidone or nintedanib) for at least 2 months prior to Day 0 or naive/not receiving these drugs for at least 4 weeks prior to Day 0 with no plans to start
- Stable monotherapy for pulmonary hypertension for at least 4 weeks prior to Day 0 and plans to remain stable during the study
- 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...
- Pre-bronchodilator FEV1/FVC ratio less than 0.7 indicating airway obstruction
- Other clinically significant pulmonary abnormalities as judged by the investigator
- Known significant pulmonary arterial hypertension with right heart failure or requiring combination or parenteral therapies
- Emphysema affecting 50% or more of lungs or greater than fibrosis extent on recent HRCT
- Acute IPF exacerbation within 6 weeks prior to screening or during screening
- Interstitial lung disease from other known causes
- 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 the trial (being on transplant list allowed)
- Elevated liver enzymes or impaired kidney function below specified limits
- Chronic liver disease with Child Pugh A, B, or C hepatic impairment
- Severe uncontrolled hypertension or recent myocardial infarction or unstable angina
- Known bleeding risk or use of full-dose anticoagulation or high-dose antiplatelet therapy
- History of hemorrhagic central nervous system event within 12 months
- Recent hemoptysis, hematuria, active gastrointestinal bleeding or peptic ulcer disease within 3 months
- Coagulation abnormalities exceeding defined thresholds
- Thrombotic events including stroke or transient ischemic attack within 12 months
- Use of certain immunosuppressive medications within 6 months
- Use of systemic corticosteroids over prednisone 15mg/day within 2 weeks
- Simultaneous use of both pirfenidone and nintedanib at screening
- Other diseases or conditions that may interfere with participation or safety
- Active or suspected malignancy within 5 years except certain skin cancers or monitored prostate cancer
- Active infection including recent COVID-19 infection within 4 weeks prior to Day 0 or during screening
- Women who are pregnant, nursing, or planning pregnancy during the trial
- Women of childbearing potential not willing or able to use highly effective birth control
- Active alcohol or drug abuse
- Inability to understand or follow trial procedures including questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
I
Ines Macias-Perez, PhD
CONTACT
I
Ingrid Anderson, PhD, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here