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EGCG for Pulmonary Fibrosis

Phase 1

Recruiting

Led By Fernando Martinez, MD

Research Sponsored by Hal Chapman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 weeks

Summary

"This trial aims to see if a specific type of imaging test using a collagen-targeted PET probe can help understand the effects of a drug called EGCG and determine the right dosage to use."

Who is the study for?

This trial is for individuals with Pulmonary Fibrosis or Idiopathic Pulmonary Fibrosis. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have a confirmed diagnosis of the conditions mentioned.

What is being tested?

The study is testing the effects of EGCG at two different doses (300 mg and 600 mg) compared to placebos. It uses a PET imaging probe called Gallium-68 (68Ga)-CBP8 to see if it can show how well EGCG works in treating fibrosis and help choose the right dose.

What are the potential side effects?

While specific side effects are not listed, EGCG is generally considered safe with possible mild side effects like stomach upset or constipation. The PET imaging agent used may cause allergic reactions or discomfort at the injection site.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function test shows an eGFR below 30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in collagen probe uptake over the entire lungs

Other study objectives

Change in peak enhancement over the entire lungs

Change in the area under the curve at 60 seconds over the entire lungs

Change in the full width at half maximum over the entire lungs

+2 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: EGCG 300 mgActive Control2 Interventions

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided anti-fibrotic for 12 weeks.

Group II: EGCG 600 mgActive Control2 Interventions

Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided anti-fibrotic for 12 weeks.

Group III: Placebo for EGCG 300 mgPlacebo Group2 Interventions

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided anti-fibrotic. The number of placebo capsules will be equal to that of 300 mg EGCG.

Group IV: Placebo for EGCG 600 mgPlacebo Group2 Interventions

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided anti-fibrotic. The number of placebo capsules will be equal to that of 600 mg EGCG.

0 / 1Eligibility criteria met