Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Part of paid clinical trials in La Mesa, California.
- Sponsor
- Cumberland Pharmaceuticals
- Study ID
- NCT05571059
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Idiopathic Pulmonary Fibrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ifetroban Sodium — DRUGOnce daily oral ifetroban
- Placebo — DRUGMatching oral placebo
Study Details
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 Dates
- Start date
- Jan 31, 2024
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 128 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ifetroban SodiumDrug: Ifetroban Oral capsule, 250 mg, once daily for 12 months
- Placebo Comparator: PlaceboDrug: Placebo Matching placebo, oral capsule, once daily for 12 months
Primary Outcome Measure
Change from baseline in Forced Vital Capacity (FVC) in mL [ Time Frame: Baseline through 12 months ]
Central Contacts
- Ines Macias-Perez, PhD6159795778
- Ingrid Anderson, PhD, CCRP615-627-4121
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Biosolutions Clinical Research | La Mesa | California | 91942 | Kaveh Bagheri, MD (PRINCIPAL_INVESTIGATOR) |
| University of California San Francisco | San Francisco | California | 94143 | Jeffrey Golden, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | Augustine Lee, MD (PRINCIPAL_INVESTIGATOR) |
| Miami VA Health System | Miami | Florida | 33125 | Robert Jackson, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Medicine | Chicago | Illinois | 60611 | Krishnan Warrior, MD (PRINCIPAL_INVESTIGATOR) |
| Indiana University Health | Indianapolis | Indiana | 46202 | Damien Patel, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas | Kansas City | Kansas | 66160 | Mark Hamblin, MD (PRINCIPAL_INVESTIGATOR) |
| University of Louisville | Louisville | Kentucky | 40202 | Mohamed Saad, MD (PRINCIPAL_INVESTIGATOR) |
| Beaumont Hospital, Royal Oak | Royal Oak | Michigan | 48073 | Enrique Calvo-Ayala, MD (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Maria Padilla, MD (PRINCIPAL_INVESTIGATOR) |
| University of Rochester | Rochester | New York | 14642 | David Nagel, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27514 | |
| Bend Memorial Hospital | Bend | Oregon | 97701 | Jeremy Feldman, MD (PRINCIPAL_INVESTIGATOR) |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | Gerard Criner, MD (PRINCIPAL_INVESTIGATOR) |
| Avera Research Institute | Sioux Falls | South Dakota | 57108 | Fady Jamous, MD (PRINCIPAL_INVESTIGATOR) |
| Pulmonary & Sleep Specialists | Dickson | Tennessee | 37055 | Mohammad Alsoub, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor University Medical Center | Dallas | Texas | 75246 | Susan Mathai, MD (PRINCIPAL_INVESTIGATOR) |
| Premier Pulmonary Critical Care and Sleep Medicine | Denison | Texas | 75020 | Sanober Kable, MD (PRINCIPAL_INVESTIGATOR) |
| UW Health University Hospital | Madison | Wisconsin | 53792 |
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