Early Phase 1
N=35
Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03928847 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: EGCG PK Level in Healthy Volunteers — NA; NA; NA; 861 nM
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Epigallocatechin-3-gallate (EGCG) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Hal Chapman
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EGCG PK Level in Healthy Volunteers |
NA; NA; NA; 861; 612; 3126 | — |
| PRIMARY Change of Serum Biomarker COMP Before and After EGCG Treatment in ILD Patients |
137.2; 97.9 | <0.01 sig |
| PRIMARY Change of Serum Biomarker Periostin Before and After EGCG Treatment in ILD Patients |
41.9; 35.2 | <0.01 sig |
| PRIMARY Difference of Biomarker Snail1 Between EGCG-treated and Non-treated Patient Groups |
0.825; 0.132 | <0.01 sig |
| PRIMARY Difference of Biomarker Collagen I Between EGCG-treated and Non-treated Patient Groups |
0.894; 0.136 | <0.01 sig |
| PRIMARY Difference of Biomarker p-Smad3 Between EGCG-treated and Non-treated Patient Groups |
0.913; 0.284 | <0.01 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03928847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.