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Recruiting Phase 2 NCT05571059

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Trial Parameters

Condition Idiopathic Pulmonary Fibrosis
Sponsor Cumberland Pharmaceuticals
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 128
Sex ALL
Min Age 40 Years
Max Age N/A
Start Date 2024-01-31
Completion 2027-01
Interventions
Ifetroban SodiumPlacebo

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Male or female age 40 years or older 2. IPF Diagnosis: 1. 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 2. UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP. 3. 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). 4. If receiving monotherapy for the treatment of pulmonary hypertension (e.g. phosphodiesterase 5 inhibitors, e

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