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

  • STATUS
    Recruiting
  • End date
    Dec 3, 2022
  • participants needed
    35
  • sponsor
    University of California, San Francisco
Updated on 3 February 2021
pulmonary disease
interstitial lung disease
lung biopsy

Summary

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.

Description

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.

Details
Condition Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment Epigallocatechin-3-gallate (EGCG)
Clinical Study IdentifierNCT03928847
SponsorUniversity of California, San Francisco
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

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
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