Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.
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|ClinicalTrials.gov Identifier: NCT03928847|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Epigallocatechin-3-gallate (EGCG)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: EGCG treatment
Healthy volunteers: 450 mg, 600 mg, or 750 mg Epigallocatechin-3-gallate (EGCG) capsules administered once daily by mouth
Patients: 600 mg EGCG capsules once daily by mouth for two weeks
Drug: Epigallocatechin-3-gallate (EGCG)
Epigallocatechin-3-gallate (EGCG) capsules
Other Name: Teavigo
- Analysis of biomarker levels from Lung tissue specimens [ Time Frame: Day 14 ]LOXL2 activity and TGFbeta1 signaling biomarkers such as Snail1 and pSmad3 will be measured in lung tissue from subjects treated with EGCG and compared levels seen in to lung tissue from untreated control subjects.
- Change from baseline in urinary biomarkers of LOXL2 collagen crosslinking [ Time Frame: Change from day 1 to day 14 ]Change from baseline to day 14 in biomarkers representative of LOXL2 collagen crosslinking will be measured in urine samples collected on day 1 and day 14.
- Analysis of serum biomarker Periostin and COMP levels from blood specimens [ Time Frame: Change from day 1 to day 14 ]Change from baseline to day 14 in serum biomarkers associated with IPF
- Maximum plasma concentration of EGCG [ Time Frame: 0, 2, 4, 12 hours post dose ]The maximum plasma concentration [Cmax] following a single dose of EGCG will be determined
- Plasma exposure of EGCG [ Time Frame: 0, 2, 4, 12 hours post dose ]Plasma exposure measured as AUC (area under the concentration curve) following a single dose of EGCG will be determined.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of EGCG [ Time Frame: 14 days ]The incidence of treatment-emergent Adverse Events [Safety and Tolerability] following EGCG treatment will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928847
|Contact: Hal A Chapman, MD||415-514-1210||Hal.Chapman@ucsf.edu|
|United States, California|
|UC San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Hal A Chapman, MD 415-514-1210|
|Principal Investigator:||Hal A Chapman, MD||UC San Francisco|