None listed
Conditions
Interventions
Drug : Investigational product: Pirfenidone (Pirespa tab) will be administered orally three times daily after meals. Based on the subject’s response and tolerability, the dose may be increased by one
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged =19 years at the time of written informed consent. Subjects diagnosed with non-idiopathic pulmonary fibrosis (non-IPF) interstitial lung disease (ILD) based on clinical and radiological findings, with a usual interstitial pneumonia (UIP) pattern confirmed on screening high-resolution computed tomography (HRCT) (*defined as UIP or probable UIP). Subjects with a forced vital capacity (FVC) % predicted =45% at Visit 2. Subjects with a diffusing capacity of the lung for carbon monoxide (DLco), corrected using hemoglobin (Hb) value from Visit 1, of =30% and <80% predicted at Visit 2. Subjects with a 6-minute walk distance (6MWD) =150 m at Visit 2.
Exclusion criteria
Exclusion criteria: one. Subjects diagnosed with idiopathic pulmonary fibrosis (IPF). two. Subjects with a forced expiratory volume in one second to forced vital capacity (FEV1/FVC) ratio less than zero point seven on screening spirometry. three. Subjects with any of the following significant systemic diseases: Severe hepatic impairment: • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times the upper limit of normal at screening • Total bilirubin greater than one point five times the upper limit of normal at screening • End-stage liver disease (Child-Pugh class C) Severe renal impairment: • Creatinine clearance less than thirty milliliters per minute at screening • End-stage renal disease requiring dialysis Clinically significant pulmonary abnormalities other than interstitial lung disease Pulmonary hypertension requiring pharmacological treatment Uncontrolled hypertension (systolic blood pressure greater than or equal to one hundred sixty millimeters of mercury at screening) Active infection that may affect pulmonary function testing or interstitial lung disease treatment (e.g., bronchitis, sinusitis) Unstable psychiatric disorders not adequately controlled with medication History of photosensitivity History of angioedema Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption four. Subjects with a life expectancy of less than twelve months at screening. five. Subjects with a history of treatment with pirfenidone or nintedanib. six. Subjects with known hypersensitivity to the investigational product or any of its active substances or excipients. seven. Subjects requiring concomitant administration of fluvoxamine during the study period. eight. Subjects who have received the following interstitial lung disease related therapies (for interstitial lung disease treatment purposes; use for other indications is excluded): Rituximab within six months prior to Visit two Azathioprine, mycophenolate mofetil (MMF), cyclophosphamide, or cyclosporine within four weeks prior to Visit two High-dose systemic corticosteroids (prednisolone greater than fifteen milligrams per day or equivalent) for a total duration of at least twenty-eight days within four weeks prior to Visit two nine. Subjects who are unable to abstain from smoking during the study period. ten. Subjects scheduled for surgical procedures requiring general anesthesia during the study period (minor procedures without dietary restriction are excluded). eleven. Subjects with a history of malignancy within five years prior to screening, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or thyroid cancer. twelve. Subjects with a history of alcohol or drug abuse within one year prior to screening. thirteen. Subjects with clinically significant cardiovascular or cerebrovascular events within six months prior to screening, including stroke, unstable angina, myocardial infarction, transient ischemic attack, hospitalization for congestive heart failure, or uncontrolled arrhythmia. fourteen. Subjects who received any investigational medicinal product within twelve weeks prior to screening or are currently participating in another clinical trial, except for observational or retrospective studies that are not expected to affect study outcomes. fifteen. Pregnant or breastfeeding women, or subjects who do not agree to use highly effective contraceptio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and safety of pirfenidone | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FVC(Forced vital capacity) (mL) from baseline to Week 52;Change in 6MWD (6-minute walk distance) from baseline to Week 52;Change in K-BILD(King’s Brief Interstitial Lung Disease Questionnaire) total score from baseline to Week 52;Time to first acute ILD(interstitial lung disease) exacerbation or death over 52 weeks;Time to death within 52 weeks | — |
Countries
Korea, Republic of
Contacts
Public ContactSugyeong Park
Asan Medical Center
Outcome results
None listed