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Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EGCG 300 mg + Nintedanib
EGCG 300 mg + Pirfenidone
Placebo 2 capsules + Nintedanib or Pirfenidone
EGCG 600 mg + Nintedanib
EGCG 600 mg + Pirfenidone
Placebo 4 capsules + Nintedanib or Pirfenidone
Sponsored by
Hal Chapman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, epigallocatechin-3-gallate, EGCG

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female, aged 40-85 years old
  4. Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.
  5. Participant must have been on a stable dose of nintedanib or pirfenidone for at least 12 weeks prior to baseline (Visit 2).
  6. Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI)
  7. Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI
  8. 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.
  9. Participant has a life expectancy of at least 9 months at Visit 1.
  10. Ability to take oral medication and be willing to adhere to EGCG regimen.
  11. Agreement to refrain from drinking green tea in excess of a cup a day or eating green tea extract for 4 weeks before baseline and during the trial.

Exclusion Criteria:

  1. AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit
  2. Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis
  3. Alcohol consumption greater than 7 drinks per week
  4. Participant has emphysema ≥ 50% or the extent of emphysema is greater than the extent of fibrosis as per interpretation of Site Investigator or radiologist
  5. Participant has received investigational therapy for IPF within 4 weeks before baseline (Visit 2)
  6. Participant is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks of baseline visit (Visit 2)
  7. 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.
  8. Participant has baseline resting oxygen saturation of < 89% on room air or need for continuous oxygen use at baseline visit (Visit 2).
  9. Consumption of GTE products in excess of a cup of green tea a day within one month of the baseline visit (Visit 2).
  10. Participant is receiving digoxin at the time of screening (Visit 1) and for the duration of the study.
  11. Active respiratory infection requiring treatment with antibiotics within 4 weeks of the baseline visit (Visit 1).

Sites / Locations

  • UCSF ParnassusRecruiting
  • Massachusetts General HospitalRecruiting
  • Cornell UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

EGCG 300 mg with Nintedanib

EGCG 300 mg with Pirfenidone

Placebo for EGCG 300 mg

EGCG 600 mg with Nintedanib

EGCG 600 mg with Pirfenidone

Placebo for EGCG 600 mg

Arm Description

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Nintedanib for 12 weeks.

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 300 mg EGCG.

Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided Nintedanib for 12 weeks.

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 600 mg EGCG.

Outcomes

Primary Outcome Measures

Participants with treatment-emergent adverse event (TEAE)
The number of participants with at least 1 treatment-emergent adverse event
The number of treatment-emergent adverse events (TEAE)
The number of treatment-emergent adverse events
Participants with grade 3 or 4 treatment-emergent adverse events (TEAE)
The number of participants with at least 1 grade 3 or 4 treatment-emergent adverse events
The number of grade 3 or 4 treatment-emergent adverse events (TEAE)
The number of grade 3 or 4 treatment-emergent adverse events
Participants with serious adverse event (SAE)
The number of participants with at least 1 serious adverse event
The number of serious adverse event (SAE)
The number of serious adverse events
Participants with discontinued study treatment due to adverse events (AE)
The number of participants who discontinued study treatment due to adverse events
Participants with discontinued study treatment due to serious adverse events (SAE)
The number of participants who discontinued study treatment due to serious adverse events
Participants died due to adverse events (AE) on study treatment
The number of participants who died due to adverse events on study treatment
Participants died due to adverse events (AE) within 4 weeks of discontinuation
The number of participants who died due to adverse events within 4 weeks of discontinuation from study treatment
Participants with adverse event (AE) by causality
The number of participants with at least 1 adverse event by causality (reasonable possibility/no reasonable possibility)
Adverse events (AE) by causality
The number of adverse events by causality (reasonable possibility/no reasonable possibility)
Change in individual laboratory parameters
Absolute and relative change in individual laboratory parameters from baseline at day 84
Change in forced vital capacity (FVC)
Absolute and relative change in forced vital capacity from baseline at day 84
Change in forced vital capacity (FVC) % predicted
Absolute and relative change in forced vital capacity % predicted from baseline at day 84
Change in diffusing capacity for carbon monoxide (DLCO)
Absolute and relative change in diffusing capacity for carbon monoxide uncorrected for hemoglobin from baseline at day 84
Change in total score for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire
Absolute change in total score for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from baseline at day 84
Participants with an absolute change in K-BILD of 5 points or more in either direction
The number of participants with an absolute change in K-BILD from baseline to day 84 of 5 points or more in either direction
Change in total score for the Leicester Cough Questionnaire (LCQ)
Absolute change in total score for the Leicester Cough Questionnaire (LCQ) from baseline at day 84
Participants with an absolute change of at least 1.5 points for the LCQ
The number of participants with an absolute change from baseline to day 84 of 1.5 points or more in either direction for the LCQ
Participants with a peak level change for nintedanib or pirfenidone over 50% from screening to baseline (day 1)
The number of participants with a change from screening to baseline (day 1) in peak levels for nintedanib or pirfenidone of 50% or more in either direction
Participants with a peak level change for nintedanib or pirfenidone over 50% from baseline to day 14
The number of participants with a change from baseline to day 14 in peak levels for nintedanib or pirfenidone of 50% or more in either direction
Participants with a trough level change for nintedanib or pirfenidone over 50% from baseline to day 14
The number of participants with a change from baseline to day 14 in trough levels for nintedanib or pirfenidone of 50% or more in either direction
Participants with peak (cmax) levels for EGCG < 250 nM at day 14
The number of participants with peak (cmax) levels for EGCG < 250 nM at day 14

Secondary Outcome Measures

Change of serum biomarker COMP at day 14
Change in level of serum biomarker COMP from baseline at day 14
Change of serum biomarker COMP at day 84
Change in level of serum biomarker COMP from baseline at day 84
Change of serum biomarker Periostin at day 14
Change in level of serum biomarker Periostin from baseline at day 14
Change of serum biomarker Periostin at day 84
Change in level of serum biomarker Periostin from baseline at day 84
Change of serum biomarker pro-MMP1 at day 14
Change in level of serum biomarker pro-MMP1 from baseline at day 14
Change of serum biomarker pro-MMP1 at day 84
Change in level of serum biomarker pro-MMP1 from baseline at day 84

Full Information

First Posted
December 2, 2021
Last Updated
September 19, 2023
Sponsor
Hal Chapman
Collaborators
University of Michigan, Cornell University, Massachusetts General Hospital, Temple University, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05195918
Brief Title
Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
Official Title
Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hal Chapman
Collaborators
University of Michigan, Cornell University, Massachusetts General Hospital, Temple University, University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This is a multi-center, double-blind, placebo-controlled, dose-ranging Phase I study of once daily EGCG administered for 12 weeks. The study will assess safety, pharmacokinetics, and biomarker measurements of drug effect in IPF patients already receiving background therapy for IPF with either nintedanib or pirfenidone. Two different doses of EGCG will be studied. The rationale for this study is 1) extensive pre-clinical data in mice that EGCG is efficacious in attenuating pulmonary fibrosis by blocking collagen cross-linking and the pro-fibrotic pathway mediated by TGFβ1 signaling and 2) recently published data demonstrating that in humans EGCG is safe and capable of blocking lung tissue pro-fibrotic signaling when given two weeks prior to diagnostic surgical biopsy of pulmonary fibrosis patients, many of whom were subsequently diagnosed with IPF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic Pulmonary Fibrosis, epigallocatechin-3-gallate, EGCG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
There will be two stages in this multi-center, double-blind, placebo-controlled, dose-ranging Phase I study. Participants will first be randomized to one of the four groups to receive 300 mg EGCG or placebo with one of the standard of care drugs (nintedanib or pirfenidone) for 12 weeks and 4 weeks follow-up. Once all 25 subjects at stage one have completed the study, a staged safety analysis will occur prior to opening stage two study with a higher group dose of 600 mg EGCG.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGCG 300 mg with Nintedanib
Arm Type
Active Comparator
Arm Description
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Nintedanib for 12 weeks.
Arm Title
EGCG 300 mg with Pirfenidone
Arm Type
Active Comparator
Arm Description
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
Arm Title
Placebo for EGCG 300 mg
Arm Type
Placebo Comparator
Arm Description
Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 300 mg EGCG.
Arm Title
EGCG 600 mg with Nintedanib
Arm Type
Active Comparator
Arm Description
Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided Nintedanib for 12 weeks.
Arm Title
EGCG 600 mg with Pirfenidone
Arm Type
Active Comparator
Arm Description
Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.
Arm Title
Placebo for EGCG 600 mg
Arm Type
Placebo Comparator
Arm Description
Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 600 mg EGCG.
Intervention Type
Combination Product
Intervention Name(s)
EGCG 300 mg + Nintedanib
Other Intervention Name(s)
epigallocatechin-3-gallate + Ofev
Intervention Description
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib
Intervention Type
Combination Product
Intervention Name(s)
EGCG 300 mg + Pirfenidone
Other Intervention Name(s)
epigallocatechin-3-gallate + Esbriet
Intervention Description
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Pirfenidone
Intervention Type
Combination Product
Intervention Name(s)
Placebo 2 capsules + Nintedanib or Pirfenidone
Other Intervention Name(s)
Placebo + Ofev or Esbriet
Intervention Description
Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone
Intervention Type
Combination Product
Intervention Name(s)
EGCG 600 mg + Nintedanib
Other Intervention Name(s)
epigallocatechin-3-gallate + Ofev
Intervention Description
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib
Intervention Type
Combination Product
Intervention Name(s)
EGCG 600 mg + Pirfenidone
Other Intervention Name(s)
epigallocatechin-3-gallate + Esbriet
Intervention Description
Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Pirfenidone
Intervention Type
Combination Product
Intervention Name(s)
Placebo 4 capsules + Nintedanib or Pirfenidone
Other Intervention Name(s)
Placebo + Ofev or Esbriet
Intervention Description
Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone
Primary Outcome Measure Information:
Title
Participants with treatment-emergent adverse event (TEAE)
Description
The number of participants with at least 1 treatment-emergent adverse event
Time Frame
Up to 12 weeks
Title
The number of treatment-emergent adverse events (TEAE)
Description
The number of treatment-emergent adverse events
Time Frame
Up to 12 weeks
Title
Participants with grade 3 or 4 treatment-emergent adverse events (TEAE)
Description
The number of participants with at least 1 grade 3 or 4 treatment-emergent adverse events
Time Frame
Up to 12 weeks
Title
The number of grade 3 or 4 treatment-emergent adverse events (TEAE)
Description
The number of grade 3 or 4 treatment-emergent adverse events
Time Frame
Up to 12 weeks
Title
Participants with serious adverse event (SAE)
Description
The number of participants with at least 1 serious adverse event
Time Frame
Up to 12 weeks
Title
The number of serious adverse event (SAE)
Description
The number of serious adverse events
Time Frame
Up to 12 weeks
Title
Participants with discontinued study treatment due to adverse events (AE)
Description
The number of participants who discontinued study treatment due to adverse events
Time Frame
Up to 12 weeks
Title
Participants with discontinued study treatment due to serious adverse events (SAE)
Description
The number of participants who discontinued study treatment due to serious adverse events
Time Frame
Up to 12 weeks
Title
Participants died due to adverse events (AE) on study treatment
Description
The number of participants who died due to adverse events on study treatment
Time Frame
Up to 12 weeks
Title
Participants died due to adverse events (AE) within 4 weeks of discontinuation
Description
The number of participants who died due to adverse events within 4 weeks of discontinuation from study treatment
Time Frame
Up to 12 weeks
Title
Participants with adverse event (AE) by causality
Description
The number of participants with at least 1 adverse event by causality (reasonable possibility/no reasonable possibility)
Time Frame
Up to 12 weeks
Title
Adverse events (AE) by causality
Description
The number of adverse events by causality (reasonable possibility/no reasonable possibility)
Time Frame
Up to 12 weeks
Title
Change in individual laboratory parameters
Description
Absolute and relative change in individual laboratory parameters from baseline at day 84
Time Frame
Up to 12 weeks
Title
Change in forced vital capacity (FVC)
Description
Absolute and relative change in forced vital capacity from baseline at day 84
Time Frame
Up to 12 weeks
Title
Change in forced vital capacity (FVC) % predicted
Description
Absolute and relative change in forced vital capacity % predicted from baseline at day 84
Time Frame
Up to 12 weeks
Title
Change in diffusing capacity for carbon monoxide (DLCO)
Description
Absolute and relative change in diffusing capacity for carbon monoxide uncorrected for hemoglobin from baseline at day 84
Time Frame
Up to 12 weeks
Title
Change in total score for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire
Description
Absolute change in total score for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from baseline at day 84
Time Frame
Up to 12 weeks
Title
Participants with an absolute change in K-BILD of 5 points or more in either direction
Description
The number of participants with an absolute change in K-BILD from baseline to day 84 of 5 points or more in either direction
Time Frame
Up to 12 weeks
Title
Change in total score for the Leicester Cough Questionnaire (LCQ)
Description
Absolute change in total score for the Leicester Cough Questionnaire (LCQ) from baseline at day 84
Time Frame
Up to 12 weeks
Title
Participants with an absolute change of at least 1.5 points for the LCQ
Description
The number of participants with an absolute change from baseline to day 84 of 1.5 points or more in either direction for the LCQ
Time Frame
Up to 12 weeks
Title
Participants with a peak level change for nintedanib or pirfenidone over 50% from screening to baseline (day 1)
Description
The number of participants with a change from screening to baseline (day 1) in peak levels for nintedanib or pirfenidone of 50% or more in either direction
Time Frame
Day 1
Title
Participants with a peak level change for nintedanib or pirfenidone over 50% from baseline to day 14
Description
The number of participants with a change from baseline to day 14 in peak levels for nintedanib or pirfenidone of 50% or more in either direction
Time Frame
Day 14
Title
Participants with a trough level change for nintedanib or pirfenidone over 50% from baseline to day 14
Description
The number of participants with a change from baseline to day 14 in trough levels for nintedanib or pirfenidone of 50% or more in either direction
Time Frame
Day 14
Title
Participants with peak (cmax) levels for EGCG < 250 nM at day 14
Description
The number of participants with peak (cmax) levels for EGCG < 250 nM at day 14
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Change of serum biomarker COMP at day 14
Description
Change in level of serum biomarker COMP from baseline at day 14
Time Frame
Day 14
Title
Change of serum biomarker COMP at day 84
Description
Change in level of serum biomarker COMP from baseline at day 84
Time Frame
Day 84
Title
Change of serum biomarker Periostin at day 14
Description
Change in level of serum biomarker Periostin from baseline at day 14
Time Frame
Day 14
Title
Change of serum biomarker Periostin at day 84
Description
Change in level of serum biomarker Periostin from baseline at day 84
Time Frame
Day 84
Title
Change of serum biomarker pro-MMP1 at day 14
Description
Change in level of serum biomarker pro-MMP1 from baseline at day 14
Time Frame
Day 14
Title
Change of serum biomarker pro-MMP1 at day 84
Description
Change in level of serum biomarker pro-MMP1 from baseline at day 84
Time Frame
Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Participant has a life expectancy of at least 9 months at Visit 1. Ability to take oral medication and be willing to adhere to EGCG regimen. Agreement to refrain from drinking green tea in excess of a cup a day or eating green tea extract for 4 weeks before baseline and during the trial. Exclusion Criteria: AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit. 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). Consumption of GTE products in excess of a cup of green tea a day within one month of the baseline visit (Visit 2). Participant is receiving digoxin at the time of screening (Visit 1) and for the duration of the study. Active respiratory infection requiring treatment with antibiotics within 4 weeks of the baseline visit (Visit 2).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wei, MD
Phone
415-514-1209
Email
ying.wei@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Harold Chapman, MD
Phone
415-514-1210
Email
hal.chapman@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold Chapman, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando J Martinez, MD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sydney Montesi
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Parnassus
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wei, MD
Phone
415-514-1209
Email
ying.wei@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Harold Chapman, MD
Phone
415-514-1210
Email
hal.chapman@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Harold Chapman, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney Montesi, MD
Phone
617-724-4030
Email
SBMONTESI@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Sydney Montesi, MD
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Peters
Email
elp2018@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Fernando Martinez
Phone
646-962-2748
Email
fjm2003@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Fernando Martinez, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28872461
Citation
Wei Y, Kim TJ, Peng DH, Duan D, Gibbons DL, Yamauchi M, Jackson JR, Le Saux CJ, Calhoun C, Peters J, Derynck R, Backes BJ, Chapman HA. Fibroblast-specific inhibition of TGF-beta1 signaling attenuates lung and tumor fibrosis. J Clin Invest. 2017 Oct 2;127(10):3675-3688. doi: 10.1172/JCI94624. Epub 2017 Sep 5.
Results Reference
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PubMed Identifier
27939076
Citation
Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7.
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Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients

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