Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT05321420
Eligibility Criteria:
Key Inclusion Criteria:
* Treatment naïve patients or those with \<6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
* Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers
* DLCO corrected for Hemoglobin (Hb) \[visit 1\] ≥ 30% and ≤90% of predicted of normal
* FVC ≥ 45% of predicted normal
Key Exclusion Criteria:
* Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \< 0.7 at Visit 1)
* 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
* Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
* Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
* Cardiovascular diseases, any of the following:
* Uncontrolled hypertension, within 3 months of Visit 1
* Myocardial infarction within 6 months of Visit 1
* Unstable cardiac angina within 6 months of Visit 1
* Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05321420
Study Brief:
Protocol Section:
NCT05321420