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:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02989168
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of IPF.
* Receiving supplemental oxygen for use at rest.
* Weight ≥ 40 kg.
* Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 30 days after the last dose of study drug.
Exclusion Criteria:
* FEV1/FVC \< 70%
* History of other interstitial lung diseases.
* Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening.
* Corticosteroid (\> 10 mg per day of prednisone or an equivalent) administered for 7 days or longer, within 30 days of screening.
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
* Female who is breast-feeding or pregnant
* Current smoker or history of smoking within 3 months from screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT02989168
Study Brief:
Protocol Section:
NCT02989168