Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT05571059

Run by

Cumberland Pharmaceuticals

People needed

128

Starts

2024-01-31

Expected to finish

2027-01-01

Last updated by the study team

2026-03-05

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female age 40 years or older
• IPF Diagnosis:
• Satisfying the 2022 American Thoracic Society/European Respiratory Society /Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu 2022) confirmed by the investigator
• UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP.
• If receiving antifibrotic agents pirfenidone or nintedanib, patients must be receiving a stable dose for ≥ 2 months prior to Day 0 and planning to stay on stable background therapy; if not receiving pirfenidone or nintedanib, patients must be naive to both drugs or not have received either for at least 4 weeks prior to Day 0 and remain off background therapy with no intention to start or re-start (combination of nintedanib and pirfenidone not allowed).
• If receiving monotherapy for the treatment of pulmonary hypertension (e.g. phosphodiesterase 5 inhibitors, endothelin receptor antagonists or inhaled or oral prostanoid therapy), patients must be receiving a stable dose for ≥ 4 weeks prior to Day 0 and planning to remain on a stable dose throughout the study.
• FVC ≥ 40% of predicted normal according to Global Lung Initiative (GLI)
• Diffusion Capacity of Carbon Monoxide (DLCO) [corrected for hemoglobin] ≥ 25% to <80% of predicted normal

You may not qualify if…

• 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:
• Severe hypertension, uncontrolled despite treatment (≥160/100 mmHg)
• Myocardial infarction within 6 months of Day 0
• Unstable cardiac angina
• Bleeding risk, any of the following:
• Known genetic predisposition to bleeding.
• Patients who require:
• i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, direct oral anticoagulants, heparin, hirudin) ii. High dose antiplatelet therapy (> 325 mg/day of aspirin; > 75 mg/day ticlodipine or clopidogrel; any dose of other 2b3a anti-platelet agents)
• History of hemorrhagic central nervous system (CNS) event within 12 months of Day 0
• Any of the following within 3 months of Day 0:
• Hemoptysis or hematuria
• Active gastro-intestinal (GI) bleeding needing hospitalization/intervention or peptic ulcer disease
• Coagulation parameters: International normalized ratio (INR) >2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by >1.5 x ULN
• Note: Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. less than or equal to enoxaparin 40 mg subcutaneously (SC) per day or heparin 5000 units SC every eight hours), low-dose FXa inhibitors (rivaroxaban/apixaban: 2.5mg twice daily (max 5mg/day), edoxaban: 15mg/day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid [ASA] up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited.
• History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Day 0

Where it is running

• Biosolutions Clinical Research — La Mesa, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Miami VA Health System — Miami, Florida, United States (enrolling)
• Northwestern Medicine — Chicago, Illinois, United States (enrolling)
• Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• University of Kansas — Kansas City, Kansas, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Beaumont Hospital, Royal Oak — Royal Oak, Michigan, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• University of Rochester — Rochester, New York, United States (enrolling)
• UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Bend Memorial Hospital — Bend, Oregon, United States (enrolling)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• Avera Research Institute — Sioux Falls, South Dakota, United States (enrolling)
• Pulmonary & Sleep Specialists — Dickson, Tennessee, United States (enrolling)
• Baylor University Medical Center — Dallas, Texas, United States (enrolling)
• Premier Pulmonary Critical Care and Sleep Medicine — Denison, Texas, United States (enrolling)
• UW Health University Hospital — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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