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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05195918
Study type	Interventional
Source	University of California, San Francisco
Contact	Ying Wei, MD
Phone	415-514-1209
Email	ying.wei@ucsf.edu
Status	Recruiting
Phase	Phase 1
Start date	August 24, 2023
Completion date	March 31, 2025

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