Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients (NCT05195918) | Clinical Trial Compass
CompletedPhase 1
Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
United States50 participantsStarted 2023-08-24
Plain-language summary
The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female, aged 40-85 years old.
✓. Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.
✓. Participant must have been on a stable dose of nintedanib twice daily or pirfenidone three times daily dose for at least 12 weeks prior to baseline (Visit 2).
✓. Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI).
✓. Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI.
✓. Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if \< 55 years or 12 months if \> 55 years, must have a negative serum pregnancy test within 1 week prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
Exclusion criteria
✕. AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit.
What they're measuring
1
Participants with treatment-emergent adverse event (TEAE)
Timeframe: Up to 12 weeks
2
The number of treatment-emergent adverse events (TEAE)
Timeframe: Up to 12 weeks
3
Participants with grade 3 or 4 treatment-emergent adverse events (TEAE)
Timeframe: Up to 12 weeks
4
The number of grade 3 or 4 treatment-emergent adverse events (TEAE)
Timeframe: Up to 12 weeks
5
Participants with serious adverse event (SAE)
Timeframe: Up to 12 weeks
6
The number of serious adverse event (SAE)
Timeframe: Up to 12 weeks
7
Participants with discontinued study treatment due to adverse events (AE)
Timeframe: Up to 12 weeks
8
Participants with discontinued study treatment due to serious adverse events (SAE)
. Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis.
✕. Alcohol consumption greater than 7 drinks per week.
✕. Participant has emphysema ≥ 50% or the extent of emphysema is greater than the extent of fibrosis as per interpretation of Site Investigator or radiologist.
✕. Participant has received investigational therapy for IPF within 4 weeks before baseline (Visit 2).
✕. Participant is receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks of baseline visit (Visit 2).
✕. Participant has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood of survival for the study duration or the participant's ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
✕. Participant has baseline resting oxygen saturation of \< 89% on room air or need for continuous oxygen use at baseline visit (Visit 2).
9
Participants died due to adverse events (AE) on study treatment
Timeframe: Up to 12 weeks
10
Participants died due to adverse events (AE) within 4 weeks of discontinuation
Timeframe: Up to 12 weeks
11
Participants with adverse event (AE) by causality
Timeframe: Up to 12 weeks
12
Adverse events (AE) by causality
Timeframe: Up to 12 weeks
13
Change in individual laboratory parameters
Timeframe: Up to 12 weeks
14
Change in forced vital capacity (FVC)
Timeframe: Up to 12 weeks
15
Change in forced vital capacity (FVC) % predicted
Timeframe: Up to 12 weeks
16
Change in diffusing capacity for carbon monoxide (DLCO)
Timeframe: Up to 12 weeks
17
Change in total score for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire
Timeframe: Up to 12 weeks
18
Participants with an absolute change in K-BILD of 5 points or more in either direction
Timeframe: Up to 12 weeks
19
Change in total score for the Leicester Cough Questionnaire (LCQ)
Timeframe: Up to 12 weeks
20
Participants with an absolute change of at least 1.5 points for the LCQ
Timeframe: Up to 12 weeks
21
Participants with a peak level change for nintedanib or pirfenidone over 50% from screening to baseline (day 1)
Timeframe: Day 1
22
Participants with a peak level change for nintedanib or pirfenidone over 50% from baseline to day 14
Timeframe: Day 14
23
Participants with a trough level change for nintedanib or pirfenidone over 50% from baseline to day 14
Timeframe: Day 14
24
Participants with peak (cmax) levels for EGCG < 250 nM at day 14