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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT01629667
Eligibility Criteria:
Key Inclusion Criteria:
* 1\) IPF diagnosis for \<= 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required) 3)Mild to moderate IPF to include all of the following at screening:
1. FVC \>= 50% predicted normal
2. Partial pressure of oxygen in arterial blood (PaO2) of \>= 55 mmHg on room air or 50 mmHg at high altitude (\> 1500 meters), or oxygen saturation by pulse oximetry (SpO2) of \>= 90%on room air at rest
3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) \>= 30% predicted normal 4) Be able to walk \>= 100 meters unassisted
Key Exclusion Criteria:
1. A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)
2. The extent of emphysema on the HRCT is greater than the extent of fibrosis.
3. Currently listed for lung transplantation
4. Use of the following medications:
1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1 (screening). Oral prednisone \<= 15 mg/day (or equivalent oral corticosteroid) is allowed for chronic use if subject was on a stable dose at least 30 days prior to Visit 1 (screening)
2. Pirfenidone within 4 weeks prior to Visit 1 (screening)
3. N-acetylcysteine within 4 weeks prior to Visit 1 (screening)
4. Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
79 Years
Study:
NCT01629667
Study Brief:
Protocol Section:
NCT01629667