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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT01424033
Eligibility Criteria:
Inclusion:
1. Subject gives voluntary written informed consent to participate in the study.
2. Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.
3. Males and females age greater than 18 years at time of screening.
4. Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.
Exclusion:
1. History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.
2. Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.
3. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01424033
Study Brief:
Protocol Section:
NCT01424033