🏛️ Verified NIH Record • Updated 2026-03-03
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) (NCT05571059)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Cumberland Pharmaceuticals
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (35 items).
Location: Biosolutions Clinical Research — La Mesa, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70% (FEV1/FVC \< 0.7))
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Known significant PAH, defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing a cardiac index \< 2 L/min/m2, or PAH requiring combination of PAH-specific therapies or any PAH parenteral therapy.
- Emphysema ≥ 50% on HRCT assessed by the investigator, or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent chest HRCT.
- Acute IPF exacerbation within 6 weeks prior to screening and/or during the screening period (investigator-determined).
- ILD associated with other known causes
- Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Day 0 and/or during the screening period.
- Major surgery (major according to the investigator's assessment) performed within six weeks prior to Day 0 or planned during the course of the trial. (Being on a transplant list is allowed).
- AST or ALT \> 1.5 x ULN, Bilirubin \> 1.5 x ULN, Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault formula.
- Underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
- Cardiovascular diseases, any of the following:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- Biosolutions Clinical Research — La Mesa, California
- University of California San Francisco — San Francisco, California
- Mayo Clinic Jacksonville — Jacksonville, Florida
- Miami VA Health System — Miami, Florida
- Northwestern Medicine — Chicago, Illinois
- Indiana University Health — Indianapolis, Indiana
- University of Kansas — Kansas City, Kansas
- University of Louisville — Louisville, Kentucky
- Beaumont Hospital, Royal Oak — Royal Oak, Michigan
- Icahn School of Medicine at Mount Sinai — New York, New York
- University of Rochester — Rochester, New York
- UNC Chapel Hill — Chapel Hill, North Carolina
- Bend Memorial Hospital — Bend, Oregon
- Temple University Hospital — Philadelphia, Pennsylvania
- Avera Research Institute — Sioux Falls, South Dakota
- Pulmonary & Sleep Specialists — Dickson, Tennessee
- Baylor University Medical Center — Dallas, Texas
- Premier Pulmonary Critical Care and Sleep Medicine — Denison, Texas
- UW Health University Hospital — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.