Idiophatic Pulmonary Fibrosis (IPF)
Conditions
Interventions
Product Name: Pirfenidone
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pirfenidone
CAS Number: 5317-13-8
Current Sponsor code: PIR, S-7701
Concentration unit: mg milligram(s)
Concentration
Sponsors
InterMune, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical symptoms consistent with IPF, including the insidious onset of otherwise unexplained dyspnea on exertion, of more or equal to 3 months duration 2. Diagnosis of IPF, defined as first instance in which a patient was informed of having IPF, within 48 months of randomization 3. Age 40 through 80 years, inclusive 4. High-resolution computed tomographic (HRCT) scan showing a pattern of disease consistent with a confident (definite) radiographic diagnosis of usual interstitial pneumonia (UIP)/IPF. For patients with surgical lung biopsy showing definite or probable UIP, the HRCT criterion of probable (UIP)/IPF is sufficient. 5. For patients aged =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator 2. Premature withdrawal from a randomized IPF clinical trial in the previous 2 years for any reason other than Sponsor decision or current participation in a clinical drug trial 3. Forced expiratory volume in the first second (FEV1)/FVC ratio 12% predicted or 200 mL after bronchodilator use 5. The change in FVC between the Screen Visit and Day 1 (Baseline) cannot vary by more than 10% absolute difference and the Bronchodilator Response, Baseline FVC and FEV1/FVC ratio must all continue to meet the inclusion and exclusion criteria 6. Residual volume (RV) >120% of predicted (before administration of bronchodilator) 7. History of clinically significant environmental exposure known to cause PF (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds) 8. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis and cancer 9. Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis 10. Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis 11. On a lung transplantation waiting list at time of randomization 12. Unable to undergo pulmonary function testing 13. Any history of malignancy likely to result in death or significant disability or likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma) 14. Any condition other than IPF which, in the opinion of the investigator, is likely to result in the death of the patient within the next 2 years 15. History of advanced cirrhosis or clinically significant liver disease 16. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months, including but not limited to the following: a. Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty b. Congestive heart failure requiring hospitalization c. Uncontrolled arrhythmias d. Asthma or chronic bronchitis requiring hospitalization in the last 6 months 17. Any condition, which, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone 18. Poorly controlled diabetes (defined by glycosolated hemoglobin [HbA1C] >10) 19. Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to practice abstinence or prevent pregnancy by two methods of birth control from the date of screening through the duration of the study (i.e. oral contraception and a spermicide, diaphragm and a spermicide, etc.). 20. History of alcohol or substance abuse in the past 2 years 21. History of any condition or habit associated with altered consciousness and a risk of aspiration in the past 2 years 22. Family or personal history of long QT-wave syndrome 23. Any of the following liv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to assess the efficacy of treatment with pirfenidone 2403 mg/d compared with placebo in patients with idiophatic pulmonary fibrosis - to assess the safety of treatment with pirfenidone 2403 mg/d compared with placebo in patients with idiophatic pulmonary fibrosis ;Secondary Objective: ;Primary end point(s): The absolute change in percent predicted FVC from baseline to week 60. | — |
Countries
Belgium, Czech Republic, Germany, Ireland, Spain
Outcome results
None listed