Phase
Condition
Idiopathic Pulmonary Fibrosis
Cystic Fibrosis
Pulmonary Fibrosis
Treatment
Placebo
SB17170
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult male/female 40 years or older at the time of obtaining informed consent
Patients diagnosed with idiopathic pulmonary fibrosis who meet the followingcriteria:
Patients with idiopathic pulmonary fibrosis who are confirmed by chestHigh-Resolution Computed Tomography (HRCT) scan
Patients with Usual Interstitial Pneumonia (UIP) or probable UIP HRCT patternconsistent with a diagnosis of idiopathic pulmonary fibrosis confirmed throughcentral reading of chest HRCT before the baseline visit
Patients with a history of idiopathic pulmonary fibrosis treatment who meet thedefined criteria
Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at thescreening visit
Patients meeting pulmonary function test criteria at the screening visit
Patients who have received the explanation of this clinical trial and voluntarilyagreed and signed the informed consent form
Exclusion
Exclusion Criteria:
When there is a primary disease showing UIP patterns (rheumatoid arthritis-relatedinterstitial lung disease, connective tissue disease-related interstitial lungdisease, etc.) and/or other clinically significant lung abnormalities
Patients with confirmed acute exacerbation of IPF within 6 months prior to screeningand/or during the screening period
Patients with lower respiratory tract infections requiring antibiotic treatment
Patients who underwent major surgery within 3 months before screening or have majorsurgery planned during the clinical trial
Patients with a history of malignancy or documented evidence of active or suspectedmalignancy within 5 years prior to screening
Patients with evidence of active infection
Patients with the following cardiovascular and cerebrovascular diseases at the timeof screening:
Severe hypertension within 3 months
Myocardial infarction or unstable angina within 6 months
History of thrombotic events within 6 months
Diagnosis of heart failure within 6 months
Patients with pulmonary hypertension
Patients who are unable to take drugs orally or have a history of majorgastrointestinal surgery or pathological findings that may affect the absorption ofthe investigational product
Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B orC
Study Design
Study Description
Connect with a study center
Myong Ji Hospital
Goyang,
Korea, Republic ofActive - Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong,
Korea, Republic ofActive - Recruiting
Seoul Asan Hospital
Seoul,
Korea, Republic ofSite Not Available
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul,
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon,
Korea, Republic ofSite Not Available
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