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

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.

Conditions

• Idiopathic Pulmonary Fibrosis

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

Sponsors & Collaborators

• University of Michigan

  collaborator OTHER

• Cornell University

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Temple University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Hal Chapman

  lead OTHER

Principal Investigators

• Harold Chapman, MD · University of California, San Francisco

• Fernando J Martinez, MD · Cornell University

• Sydney Montesi · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-24

Primary Completion

2026-03-19

Completion

2026-03-19

FDA Drug

Yes

Countries

• United States

Study Locations