Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
Idiopathic Pulmonary Fibrosis
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, epigallocatechin-3-gallate, EGCG
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 40-85 years old
- Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.
- Participant must have been on a stable dose of nintedanib or pirfenidone for at least 12 weeks prior to baseline (Visit 2).
- Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI)
- Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI
- 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.
- Participant has a life expectancy of at least 9 months at Visit 1.
- Ability to take oral medication and be willing to adhere to EGCG regimen.
- 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:
- AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit
- Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis
- Alcohol consumption greater than 7 drinks per week
- Participant has emphysema ≥ 50% or the extent of emphysema is greater than the extent of fibrosis as per interpretation of Site Investigator or radiologist
- Participant has received investigational therapy for IPF within 4 weeks before baseline (Visit 2)
- Participant is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks of baseline visit (Visit 2)
- 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.
- Participant has baseline resting oxygen saturation of < 89% on room air or need for continuous oxygen use at baseline visit (Visit 2).
- Consumption of GTE products in excess of a cup of green tea a day within one month of the baseline visit (Visit 2).
- Participant is receiving digoxin at the time of screening (Visit 1) and for the duration of the study.
- Active respiratory infection requiring treatment with antibiotics within 4 weeks of the baseline visit (Visit 1).
Sites / Locations
- UCSF ParnassusRecruiting
- Massachusetts General HospitalRecruiting
- Cornell UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
EGCG 300 mg with Nintedanib
EGCG 300 mg with Pirfenidone
Placebo for EGCG 300 mg
EGCG 600 mg with Nintedanib
EGCG 600 mg with Pirfenidone
Placebo for EGCG 600 mg
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Nintedanib for 12 weeks.
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 300 mg EGCG.
Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided Nintedanib for 12 weeks.
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 600 mg EGCG.