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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT03208933
Eligibility Criteria:
Inclusion Criteria:
* Clinical symptoms consistent with IPF of ≥ 6months duration
* Participants could have both "confident" or "consistent" with UIP diagnosis of IPF based on clinical, radiologic and pathologic data according to 2011 American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines at the Screening. HRCT scan performed within 24 months before the start of the Screening may be used, if it meets all image acquisition guideline
* No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or surgical lung biopsy, if performed. Results of the surgical lung biopsy performed within the last 4 years must be confirmed by central review
* Participants with %FVC ≥ 40 % at the Screening
* Participants with %Carbon monoxide diffusing capacity (DLCO) ≥ 30 % at the Screening
* Ability to walk ≥ 100 m during the 6-minute walk test at the Screening
* Eligible participants must discontinue all prohibited medications at least 28 days before the Screening
* Female participants of childbearing potential must have negative urine pregnancy test at the Screening and before first dosing on Day 1
Exclusion Criteria:
* Significant clinical worsening of IPF between Screening and Day 1, in the opinion of the investigator
* Relevant airways obstruction (i.e. pre-bronchodilator forced expiratory volume (FEV)1/FVC \< 0.7)
* Cigarette smoking within 28 days before the start of treatment or unwilling to avoid tobacco products throughout the study
* History of clinically significant environmental exposure known to cause pulmonary fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds
* Known explanation for interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
* Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/ dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
* During baseline analysis of HRCT, significant coexistent emphysema (emphysema extent greater than extent of fibrosis) confirmed by central review
* Planned lung transplantation during the study
* Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
* Unable to perform 6MWT or to undergo pulmonary function test
* Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 1 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma)
* History of severe hepatic impairment or end-stage liver disease
* History of end-stage renal disease requiring dialysis
* History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
* Pregnancy or lactation, or intention to become pregnant during the study. Women of childbearing capacity are required to have a negative urine pregnancy test before treatment and must agree to maintain highly effective contraception
* Liver function test outside specified limits at the Screening: total bilirubin above the upper limit of normal (ULN); aspartate or alanine aminotransferase (AST or ALT) \> 3 × ULN; alkaline phosphatase \> 2.5 × ULN
* Creatinine clearance \< 30 mL/min, calculated using the Cockcroft-Gault formula
* Electrocardiogram (ECG) with a QT interval corrected according to Fridericia's formula (QTcF) \> 500 msec at the Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03208933
Study Brief:
Protocol Section:
NCT03208933