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New treatment option for Idiopathic Pulmonary Fibrosis
Official title Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
ClinicalTrials.gov ID: NCT05571059
What this study is testing
What is Ifetroban Sodium?
Ifetroban Sodium is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Also referred to as ifetroban.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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...
- 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...
You likely can't join if
- Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70% (FEV1/FVC \<...
- 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...
- Emphysema ≥ 50% on HRCT assessed by the investigator, or the extent of emphysema is greater than the extent of fibrosis according to reported results...
- Acute IPF exacerbation within 6 weeks prior to screening and/or during the screening period (investigator-determined).
- ILD associated with other known causes
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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 (\>...
- 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...
- History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Day 0
- Use of disease-modifying antirheumatic drugs, B-cell depleting therapies or immunosuppressive medications, within 6 months of Day 0.
- Use of systemic corticosteroids equivalent to prednisone \>15mg/day within 2 weeks of Day 0.
- Simultaneous use of pirfenidone and nintedanib at screening.
- Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
- Any documented active or suspected malignancy within 5 years prior to Day 0, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or "under surveillance" prostate...
- Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings.
- The patient has a confirmed infection with Severe Acute Respiratory Syndrome- Coronvirus-2 (SARS-CoV-2) within the four weeks prior to Day 0 or during the screening period.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently for 28 days prior to...
- In the opinion of the Investigator, active alcohol or drug abuse.
- Patients not able to understand or follow trial procedures including completion of self- administered questionnaires without help.
The study team makes the final eligibility decision.
Where it's taking place
- La Mesa, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Royal Oak, Michigan, United States
- New York, New York, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Bend, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Dickson, Tennessee, United States
- Dallas, Texas, United States
- Denison, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Mesa, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.