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Purpose

The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection.

Condition

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Enrolled in and eligible (based on screening procedures - Visit 1) for the main EGCG Phase 1 study, "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 2. Signed informed consent

Exclusion Criteria

  1. Pregnant or breastfeeding (a negative quantitative serum human chorionic gonadotropin (hCG) pregnancy test is required for females having child-bearing potential before the participant can participate)* 2. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months 3. Determined by the investigator to be clinically unsuitable for the study Additional exclusion criteria for participants undergoing PET-MRI: 1. Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump 2. Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning 3. Claustrophobic reactions 4. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days 5. Known allergy to gadolinium - Women of childbearing potential (WCBP) are 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
This is an optional substudy to the phase I study: "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." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing [68Ga]CBP8 PET.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
EGCG 300 mg 		Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided anti-fibrotic for 12 weeks.
  • Drug: EGCG 300 mg
    Participants will be administered EGCG as part of the phase I study: "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."
    Other names:
    • Dietary Supplement: EGCG Capsules with EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks.
  • Drug: Placebo for EGCG 300 mg
    Participants will be administered placebo for EGCG as part of the phase I study: "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."
    Other names:
    • Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily 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 anti-fibrotic. The number of placebo capsules will be equal to that of 300 mg EGCG.
  • Drug: Placebo for EGCG 300 mg
    Participants will be administered placebo for EGCG as part of the phase I study: "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."
    Other names:
    • Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks.
Active Comparator
EGCG 600 mg 		Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided anti-fibrotic for 12 weeks.
  • Drug: EGCG 600 mg
    Participants will be administered placebo for EGCG as part of the phase I study: "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."
    Other names:
    • Dietary Supplement: EGCG Capsules with EGCG (at least 94% purity). 600 mg EGCG (4 capsules) taken orally daily for 12 weeks.
  • Drug: Placebo for EGCG 600 mg
    Participants will be administered placebo for EGCG as part of the phase I study: "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."
    Other names:
    • Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily 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 anti-fibrotic. The number of placebo capsules will be equal to that of 600 mg EGCG.
  • Drug: Placebo for EGCG 600 mg
    Participants will be administered placebo for EGCG as part of the phase I study: "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."
    Other names:
    • Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Sydney Montesi, MD
617-724-4030
SBMONTESI@PARTNERS.ORG

More Details

Status
Recruiting
Sponsor
Hal Chapman

Study Contact

Sydney Montesi, MD
617-724-4030
sbmontesi@mgb.org

Detailed Description

This is an optional sub-study of the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, pharmacokinetic (PK) interactions with standard of care drugs, and biomarkers of drug effect." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing [68Ga]CBP8 PET. Eligible participants who consent to the substudy will undergo [68Ga]CBP8 PET-CT or [68Ga]CBP8 PET-MRI at two time points. Participants will undergo 68Ga-CBP8 PET within 7 days prior to randomization and then again within 7 days prior to day 84 of the phase I study. The hypothesis is that [68Ga]CBP8 PET will detect decreased collagen deposition in individuals treated with EGCG compared to placebo.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.