Loading clinical trials...

Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients

Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect

NCT05195918•Hal Chapman

View on ClinicalTrials.gov

Summary

The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis.

Detailed Description

This is a multi-center, double-blind, placebo-controlled, dose-ranging Phase I study of once daily EGCG administered for 12 weeks. The study will assess safety, pharmacokinetics, and biomarker measurements of drug effect in IPF patients already receiving background therapy for IPF with either nintedanib or pirfenidone. Two different doses of EGCG will be studied. 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.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+2 more criteria

Locations (7)

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

Key Dates

Start Date

August 24, 2023

Primary Completion Date

April 21, 2026

Completion Date

April 21, 2026

Last Updated

January 26, 2026

Enrollment

ESTIMATED participants

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

EGCG 300 mg + Nintedanib

COMBINATION_PRODUCT

EGCG 300 mg + Pirfenidone

COMBINATION_PRODUCT

Placebo 2 capsules + Nintedanib or Pirfenidone

COMBINATION_PRODUCT

EGCG 600 mg + Nintedanib

COMBINATION_PRODUCT

EGCG 600 mg + Pirfenidone

COMBINATION_PRODUCT

Placebo 4 capsules + Nintedanib or Pirfenidone

COMBINATION_PRODUCT

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

NCT06238622

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

View study

RECRUITINGPHASE3

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

NCT07299695

Idiopathic Pulmonary FibrosisAcute Exacerbation of Idiopathic Pulmonary Fibrosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients

Inclusion Criteria

Exclusion Criteria

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

Study on the Efficacy of Quercetin Intake in Patients With Fibrotic Interstitial Lung Diseases.

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males

Validation of the C-mo System - Cough Monitoring