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

Who is this study for? Patients with Idiopathic Pulmonary Fibrosis
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Male or female, aged 40-85 years old.

• Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.

• 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).

• Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI).

• Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI.

• 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.

• Participant has a life expectancy of at least 9 months at Visit 1.

⁃ Ability to take oral medication and be willing to adhere to EGCG regimen.

⁃ Agreement to refrain from drinking green tea in excess of a cup a day or eating green tea extract for 4 weeks before baseline and during the trial.

Locations
United States
California
UCSF Parnassus
RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
New York
Weill Cornell Medicine
RECRUITING
New York
Pennsylvania
Temple University
RECRUITING
Philadelphia
Virginia
University of Virginia
NOT_YET_RECRUITING
Charlottesville
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Ying Wei, MD
ying.wei@ucsf.edu
415-514-1209
Backup
Harold Chapman, MD
hal.chapman@ucsf.edu
415-514-1210
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2026-04-21
Participants
Target number of participants: 50
Treatments
Active_comparator: EGCG 300 mg with Nintedanib
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Nintedanib for 12 weeks.
Active_comparator: EGCG 300 mg with Pirfenidone
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
Placebo_comparator: Placebo for EGCG 300 mg
Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 300 mg EGCG.
Active_comparator: EGCG 600 mg with Nintedanib
Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided Nintedanib for 12 weeks.
Active_comparator: EGCG 600 mg with Pirfenidone
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
Placebo_comparator: Placebo for EGCG 600 mg
Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 600 mg EGCG.
Sponsors
Collaborators: University of Washington, Temple University, University of Michigan, Massachusetts General Hospital, University of Virginia, Cornell University
Leads: Hal Chapman

This content was sourced from clinicaltrials.gov