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Completed

NCT Number: NCT03928847

Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.

This is a two part study. In the first part, the pharmacokinetic profile of Epigallocatechin-3-gallate (EGCG) in normal human volunteers given a single oral dose will be determined to set the dose for the second part of the study. In the second part of this study, lung biopsy fragments and urine samples from patients with interstitial lung disease treated with EGCG will be evaluated in biochemical assays and compared to samples from untreated control patients.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UC San Francisco

San Francisco, California, 94143, United States

About this study

This is an interventional study intended to test inhibition of a signaling pathway in vivo in patients with interstitial lung disease, but not intended to affect lung function or disease modifications. Doses of oral Epigallocatechin-3-gallate (EGCG) that achieve plasma levels known to be safe in human volunteers and likely to target fibroblast TGFbeta RI kinase will be established. Disposable fragments of biopsies will be evaluated in biochemical assays including pSmad3 and Snail 1 or assayed to determine lysyl oxidase-like 2 (LOXL2) protein and LOXL2 enzyme activity. Urine collected before and after EGCG exposure will be used to determine whether terminal collagen cross-link breakdown products, termed pyridinoline/deoxypyridinoline (PYD/DPD) are changed from baseline. Blood collected before and after EGCG exposure will be assayed for serum biomarkers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Part 1: healthy volunteers
  • Part 2:
  • study will consist of patients presenting to the UCSF interstitial lung disease (ILD) outpatient clinic with imaging indicative of lung fibrosis but of uncertain classification, and who are willing to take EGCG for a minimum of 2 weeks prior to surgery.

Exclusion criteria

  • co-morbidities affect hepatic function, such as HCV infection, cirrhosis, or
  • using drugs with significant hepatic toxicities

Treatment and study plan

Epigallocatechin-3-gallate (EGCG)

Drug

Epigallocatechin-3-gallate (EGCG) capsules

Other names: Teavigo

Primary outcomes

  1. EGCG PK Level in Healthy Volunteers

    Time frame: 0, 0.5, 2, 4 hours after EGCG

    EGCG plasma levels in healthy volunteers were measured at 0, 0.5, 2, and 4 hours after a single dose at 450 mg, 600 mg, or 750 mg dosage by liquid chromatography-mass spectrometry (LC-MS).

  2. Change of Serum Biomarker COMP Before and After EGCG Treatment in ILD Patients

    Time frame: Day 1 to day 14

    Change from baseline to day 14 in serum biomarkers associated with IPF, Cartilage Oligomeric Matrix Protein (COMP) measured by ELISA.

  3. Change of Serum Biomarker Periostin Before and After EGCG Treatment in ILD Patients

    Time frame: Day 1 to day 14

    Change from baseline to day 14 in serum biomarkers associated with IPF, Periostin measured by ELISA.

  4. Difference of Biomarker Snail1 Between EGCG-treated and Non-treated Patient Groups

    Time frame: 14 days

    Levels of biomarker Snail1 in lung biopsy tissues 14 days after EGCG were measured by western blot and differences were compared between EGCG-treated and non-treated groups.

  5. Difference of Biomarker Collagen I Between EGCG-treated and Non-treated Patient Groups

    Time frame: 14 days

    Levels of biomarker Collagen I in lung biopsy tissues 14 days after EGCG were measured by western blot and differences were compared between EGCG-treated and non-treated groups.

  6. Difference of Biomarker p-Smad3 Between EGCG-treated and Non-treated Patient Groups

    Time frame: 14 days

    Levels of biomarker p-Smad3 in lung biopsy tissues 14 days after EGCG were measured by western blot and differences were compared between EGCG-treated and non-treated groups.

Sponsors and collaborators

Lead sponsor

Hal Chapman

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2019
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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