Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05195918
PHASE1

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-08-24

Completion Date

2026-04-21

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

Placebo 2 capsules + Nintedanib or Pirfenidone

Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

Placebo 4 capsules + Nintedanib or Pirfenidone

Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone

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