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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT05195918
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 40-85 years old.
4. Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.
5. Participant must have been on a stable dose of nintedanib twice daily or pirfenidone three times daily dose for at least 12 weeks prior to baseline (Visit 2).
6. Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI).
7. Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI.
8. Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if \< 55 years or 12 months if \> 55 years, must have a negative serum pregnancy test within 1 week prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
9. Participant has a life expectancy of at least 9 months at Visit 1.
10. Ability to take oral medication and be willing to adhere to EGCG regimen.
11. Agreement to refrain from drinking green tea in excess of a cup a day or eating green tea extract for 4 weeks before baseline and during the trial.
Exclusion Criteria:
1. AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit.
2. Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis.
3. Alcohol consumption greater than 7 drinks per week.
4. Participant has emphysema ≥ 50% or the extent of emphysema is greater than the extent of fibrosis as per interpretation of Site Investigator or radiologist.
5. Participant has received investigational therapy for IPF within 4 weeks before baseline (Visit 2).
6. Participant is receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks of baseline visit (Visit 2).
7. Participant has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood of survival for the study duration or the participant's ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
8. Participant has baseline resting oxygen saturation of \< 89% on room air or need for continuous oxygen use at baseline visit (Visit 2).
9. Consumption of GTE products in excess of a cup of green tea a day within one month of the baseline visit (Visit 2).
10. Participant is receiving digoxin at the time of screening (Visit 1) and for the duration of the study.
11. Active respiratory infection requiring treatment with antibiotics within 4 weeks of the baseline visit (Visit 2).
12. Likely to be listed for transplant during trial participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT05195918
Study Brief:
Protocol Section:
NCT05195918