Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
NCT ID: NCT05195918
Last Updated: 2026-01-26
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2023-08-24
2026-04-21
Brief Summary
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Detailed Description
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The rationale for this study is 1) extensive pre-clinical data in mice that EGCG is efficacious in attenuating pulmonary fibrosis by blocking collagen cross-linking and the pro-fibrotic pathway mediated by TGFβ1 signaling and 2) recently published data demonstrating that in humans EGCG is safe and capable of blocking lung tissue pro-fibrotic signaling when given two weeks prior to diagnostic surgical biopsy of pulmonary fibrosis patients, many of whom were subsequently diagnosed with IPF.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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EGCG 300 mg with Nintedanib
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Nintedanib for 12 weeks.
EGCG 300 mg + Nintedanib
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
EGCG 300 mg with Pirfenidone
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
EGCG 300 mg + Pirfenidone
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Pirfenidone
Placebo for EGCG 300 mg
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.
Placebo 2 capsules + Nintedanib or Pirfenidone
Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
Drug: Pirfenidone
EGCG 600 mg with Nintedanib
Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided Nintedanib for 12 weeks.
EGCG 600 mg + Nintedanib
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
EGCG 600 mg with Pirfenidone
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
EGCG 600 mg + Pirfenidone
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Pirfenidone
Placebo for EGCG 600 mg
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.
Placebo 4 capsules + Nintedanib or Pirfenidone
Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
Drug: Pirfenidone
Interventions
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EGCG 300 mg + Nintedanib
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
EGCG 300 mg + Pirfenidone
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Pirfenidone
Placebo 2 capsules + Nintedanib or Pirfenidone
Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
Drug: Pirfenidone
EGCG 600 mg + Nintedanib
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
EGCG 600 mg + Pirfenidone
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks.
Drug: Pirfenidone
Placebo 4 capsules + Nintedanib or Pirfenidone
Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks.
Drug: Nintedanib
Drug: Pirfenidone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
85 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Cornell University
OTHER
Massachusetts General Hospital
OTHER
Temple University
OTHER
University of Washington
OTHER
University of Virginia
OTHER
Hal Chapman
OTHER
Responsible Party
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Hal Chapman
Professor
Principal Investigators
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Harold Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Fernando J Martinez, MD
Role: PRINCIPAL_INVESTIGATOR
Cornell University
Sydney Montesi
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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UCSF Parnassus
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Weill Cornell Medicine
New York, New York, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Other Identifiers
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22-35979
Identifier Type: -
Identifier Source: org_study_id
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