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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2023 |
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Main ID: |
NCT03928847 |
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Date of registration:
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18/04/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.
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Scientific title:
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Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis. |
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Date of first enrolment:
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December 1, 2017 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03928847 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Hal A Chapman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UC San Francisco |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Epigallocatechin-3-gallate (EGCG)
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Primary Outcome(s)
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Change of Serum Biomarker Periostin Before and After EGCG Treatment in ILD Patients
[Time Frame: Day 1 to day 14]
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EGCG PK Level in Healthy Volunteers
[Time Frame: 0, 0.5, 2, 4 hours after EGCG]
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Difference of Biomarker p-Smad3 Between EGCG-treated and Non-treated Patient Groups
[Time Frame: 14 days]
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Difference of Biomarker Snail1 Between EGCG-treated and Non-treated Patient Groups
[Time Frame: 14 days]
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Difference of Biomarker Collagen I Between EGCG-treated and Non-treated Patient Groups
[Time Frame: 14 days]
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Change of Serum Biomarker COMP Before and After EGCG Treatment in ILD Patients
[Time Frame: Day 1 to day 14]
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Secondary ID(s)
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17-23008
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R01HL142265
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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