Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Registration Number
- NCT05571059
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria:<br><br> 1. Male or female age 40 years or older<br><br> 2. IPF Diagnosis:<br><br> 1. Satisfying the 2022 American Thoracic Society/European Respiratory Society<br> /Japanese Respiratory Society/Latin American Thoracic Association<br> (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu 2022) confirmed by the<br> investigator<br><br> 2. UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or<br> historical lung biopsy consistent with UIP.<br><br> 3. If receiving antifibrotic agents pirfenidone or nintedanib, patients must be<br> receiving a stable dose for = 2 months prior to Day 0 and planning to stay on stable<br> background therapy; if not receiving pirfenidone or nintedanib, patients must be<br> naive to both drugs or not have received either for at least 4 weeks prior to Day 0<br> and remain off background therapy with no intention to start or re-start<br> (combination of nintedanib and pirfenidone not allowed).<br><br> 4. If receiving monotherapy for the treatment of pulmonary hypertension (e.g.<br> phosphodiesterase 5 inhibitors, endothelin receptor antagonists or inhaled or oral<br> prostanoid therapy), patients must be receiving a stable dose for = 4 weeks prior to<br> Day 0 and planning to remain on a stable dose throughout the study.<br><br> 5. FVC = 40% of predicted normal according to Global Lung Initiative (GLI)<br><br> 6. Diffusion Capacity of Carbon Monoxide (DLCO) [corrected for hemoglobin] = 25% to<br> <80% of predicted normal<br><br>Exclusion Criteria:<br><br> 1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one<br> second to forced vital capacity ratio less than 70% (FEV1/FVC < 0.7))<br><br> 2. In the opinion of the Investigator, other clinically significant pulmonary<br> abnormalities.<br><br> 3. Known significant PAH, defined as previous clinical or echocardiographic evidence of<br> significant right heart failure, history of right heart catheterization showing a<br> cardiac index < 2 L/min/m2, or PAH requiring combination of PAH-specific therapies<br> or any PAH parenteral therapy.<br><br> 4. Emphysema = 50% on HRCT assessed by the investigator, or the extent of emphysema is<br> greater than the extent of fibrosis according to reported results from the most<br> recent chest HRCT.<br><br> 5. Acute IPF exacerbation within 6 weeks prior to screening and/or during the screening<br> period (investigator-determined).<br><br> 6. ILD associated with other known causes<br><br> 7. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Day<br> 0 and/or during the screening period.<br><br> 8. Major surgery (major according to the investigator's assessment) performed within<br> six weeks prior to Day 0 or planned during the course of the trial. (Being on a<br> transplant list is allowed).<br><br> 9. AST or ALT > 1.5 x ULN, Bilirubin > 1.5 x ULN, Creatinine clearance < 30 mL/min<br> calculated by Cockcroft-Gault formula.<br><br> 10. Underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).<br><br> 11. Cardiovascular diseases, any of the following:<br><br> 1. Severe hypertension, uncontrolled despite treatment (=160/100 mmHg)<br><br> 2. Myocardial infarction within 6 months of Day 0<br><br> 3. Unstable cardiac angina<br><br> 12. Bleeding risk, any of the following:<br><br> 1. Known genetic predisposition to bleeding.<br><br> 2. Patients who require:<br><br> i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists,<br> direct thrombin inhibitors, direct oral anticoagulants, heparin, hirudin) ii. High<br> dose antiplatelet therapy (> 325 mg/day of aspirin; > 75 mg/day ticlodipine or<br> clopidogrel; any dose of other 2b3a anti-platelet agents)<br><br> 13. History of hemorrhagic central nervous system (CNS) event within 12 months of Day 0<br><br> 14. Any of the following within 3 months of Day 0:<br><br> 1. Hemoptysis or hematuria<br><br> 2. Active gastro-intestinal (GI) bleeding needing hospitalization/intervention or<br> peptic ulcer disease<br><br> 15. Coagulation parameters: International normalized ratio (INR) >2, prolongation of<br> prothrombin time (PT) and activated partial thromboplastin time (aPTT) by >1.5 x ULN<br><br> Note: Prophylactic low dose heparin or heparin flush as needed for maintenance of an<br> indwelling intravenous device (e.g. less than or equal to enoxaparin 40 mg<br> subcutaneously (SC) per day or heparin 5000 units SC every eight hours), low-dose<br> FXa inhibitors (rivaroxaban/apixaban: 2.5mg twice daily (max 5mg/day), edoxaban:<br> 15mg/day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl<br> salicylic acid [ASA] up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent<br> doses of other antiplatelet therapy) are not prohibited.<br><br> 16. History of thrombotic event (including stroke and transient ischemic attack) within<br> 12 months of Day 0<br><br> 17. Use of disease-modifying antirheumatic drugs, B-cell depleting therapies or<br> immunosuppressive medications, within 6 months of Day 0.<br><br> 18. Use of systemic corticosteroids equivalent to prednisone >15mg/day within 2 weeks of<br> Day 0.<br><br> 19. Simultaneous use of pirfenidone and nintedanib at screening.<br><br> 20. Other disease that may interfere with testing procedures or in the judgment of the<br> Investigator may interfere with trial participation or may put the patient at risk<br> when participating in this trial.<br><br> 21. Any documented active or suspected malignancy within 5 years prior to Day 0, except<br> appropriately treated basal cell carcinoma of the skin, in situ squamous cell<br> carcinoma of the skin or under surveillance prostate cancer.<br><br> 22. Evidence of active infection (chronic or acute) based on clinical exam or laboratory<br> findings.<br><br> 23. The patient has a confirmed infection with Severe Acute Respiratory Syndrome-<br> Coronvirus-2 (SARS-CoV-2) within the four weeks prior to Day 0 or during the<br> screening period.<br><br> 24. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.<br><br> 25. Women of childbearing potential not willing or able to use highly effective methods<br> of birth control per ICH M3 (R2) that result in a low failure rate of less than 1%<br> per year when used consistently for 28 days prior to and three months after<br> Investigational Medicinal Product (IMP) administration.<br><br> Note: A woman is considered of childbearing potential, i.e. fertile, following<br> menarche and until becoming post-menopausal unless permanently sterile. Permanent<br> sterilization methods include hysterectomy, bilateral salpingectomy and bilateral<br> oophorectomy<br><br> 26. In the opinion of the Investigator, active alcohol or drug abuse.<br><br> 27. Patients not able to understand or follow trial procedures including completion of<br> self- administered questionnaires without help.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in Forced Vital Capacity (FVC) in mL
- Secondary Outcome Measures
Name Time Method Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death;Time to first acute IPF exacerbation or death;Proportion of patients with acute exacerbations of lung fibrosis;Time to hospitalization for respiratory cause or death;Change from baseline in quality of life (SOBQ);Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score;Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score;Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score;Time to death;Incidence of Treatment Emergent Adverse Events (safety & tolerability)