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Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
Sponsor: Hal Chapman
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
Conditions
Interventions
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
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