CompletedPhase 1

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

United States50 participantsStarted 2023-08-24

Plain-language 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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participants with treatment-emergent adverse event (TEAE)

Timeframe: Up to 12 weeks

The number of treatment-emergent adverse events (TEAE)

Timeframe: Up to 12 weeks

Participants with grade 3 or 4 treatment-emergent adverse events (TEAE)

Timeframe: Up to 12 weeks

The number of grade 3 or 4 treatment-emergent adverse events (TEAE)

Timeframe: Up to 12 weeks

Participants with serious adverse event (SAE)

Timeframe: Up to 12 weeks

The number of serious adverse event (SAE)

Timeframe: Up to 12 weeks

Participants with discontinued study treatment due to adverse events (AE)

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT05195918

SponsorHal Chapman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-19

View on ClinicalTrials.gov More Idiopathic Pulmonary Fibrosis trials

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

Participants with treatment-emergent adverse event (TEAE)

Timeframe: Up to 12 weeks

The number of treatment-emergent adverse events (TEAE)

Timeframe: Up to 12 weeks

Participants with grade 3 or 4 treatment-emergent adverse events (TEAE)

Timeframe: Up to 12 weeks

The number of grade 3 or 4 treatment-emergent adverse events (TEAE)

Timeframe: Up to 12 weeks

Participants with serious adverse event (SAE)

Timeframe: Up to 12 weeks

The number of serious adverse event (SAE)

Timeframe: Up to 12 weeks

Participants with discontinued study treatment due to adverse events (AE)

Timeframe: Up to 12 weeks