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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04300920
Eligibility Criteria:
Inclusion Criteria:
* ≥ 40 years of age
* Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
* Signed informed consent
* If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
* Confirmed rs3570920 TT TOLLIP genotype
Exclusion Criteria:
* Pregnancy or planning to become pregnant
* Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year during study participation
* Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
* Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
* Supplemental or prescribed NAC therapy within 60 days of enrollment
* Listed for lung transplantation at the time of screening
* History of lung cancer
* Inability to perform spirometry
* Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
* Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04300920
Study Brief:
Protocol Section:
NCT04300920