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Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial (PRECISIONS)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
N-acetyl cysteine
Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, Pulmonary Fibrosis, n-acetylcysteine, NAC

Eligibility Criteria

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

Inclusion Criteria:

  • ≥ 40 years of age
  • Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
  • Signed informed consent
  • If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
  • Confirmed rs3570920 TT TOLLIP genotype

Exclusion Criteria:

  • Pregnancy or planning to become pregnant
  • Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year during study participation
  • Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
  • Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
  • Supplemental or prescribed NAC therapy within 60 days of enrollment
  • Listed for lung transplantation at the time of screening
  • History of lung cancer
  • Inability to perform spirometry
  • Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
  • Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1

Sites / Locations

  • University of ArizonaRecruiting
  • University of Southern CaliforniaRecruiting
  • Stanford UniversityRecruiting
  • University of ColoradoRecruiting
  • Piedmont HealthcareRecruiting
  • University of ChicagoRecruiting
  • Loyola UniversityRecruiting
  • Indiana UniversityRecruiting
  • University of Kansas Medical CenterRecruiting
  • Tulane UniversityRecruiting
  • Massachusetts General HospitalRecruiting
  • University of MichiganRecruiting
  • University of MinnesotaRecruiting
  • Mayo ClinicRecruiting
  • Weill Cornell MedicineRecruiting
  • University of RochesterRecruiting
  • Ohio State UniversityRecruiting
  • Temple UniversityRecruiting
  • Medical University of South CarolinaRecruiting
  • Lisa LancasterRecruiting
  • University of Texas SouthwesternRecruiting
  • University of Texas Health San AntonioRecruiting
  • University of Utah HealthRecruiting
  • University of VirginiaRecruiting
  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

600 mg oral N-acetylcysteine (NAC) three times daily for 24 months.

Placebo tablet three times daily for 24 months.

Outcomes

Primary Outcome Measures

Time to one of the following composite endpoint criteria: 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause.
This is a composite endpoint of time to 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.

Secondary Outcome Measures

Time to one of the following composite criteria: 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.
This is a composite endpoint of time to 10% relative decline in FVC % predicted, based on the global lung initiative (GLI) reference equation, first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Time to death from any cause
Time to first respiratory hospitalization
Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Time to 10% relative decline in FVC
Time to lung transplant
Time to 10% relative decline in FVC %predicted
Time to first all-cause hospitalization
Annualized rate of respiratory hospitalizations
Annualized rate of non-elective, all-cause hospitalizations
Proportion of participants undergoing lung transplant during follow-up
Change in FVC from randomization at 12 months
Change in FVC % predicted from randomization at 12 months
Change in FVC from randomization at 24 months
Change in FVC % predicted from randomization at 24 months
Change in diffusing capacity of the lung for carbon monoxide (DLCO) uncorrected for hemoglobin from randomization at 12 months
Change in DLCO from randomization at 24 months
Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 12 months.
Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 12 months.
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 12 months.
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 12 months.
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 12 months.
Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 24 months
Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 24 months
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 24 months
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 24 months
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 24 months
Proportion of participants with and number of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and unanticipated problems

Full Information

First Posted
March 6, 2020
Last Updated
March 21, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
University of Virginia, University of Michigan, Pulmonary Fibrosis Foundation, University of Washington, National Heart, Lung, and Blood Institute (NHLBI), Three Lakes Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04300920
Brief Title
Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Acronym
PRECISIONS
Official Title
Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
University of Virginia, University of Michigan, Pulmonary Fibrosis Foundation, University of Washington, National Heart, Lung, and Blood Institute (NHLBI), Three Lakes Foundation

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 purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function [10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or all-cause mortality] The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled trial of NAC or placebo in about 200 participants with IPF with a TOLLIP rs3750920 TT genotype. Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally or matched placebo to take three times daily for 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
IPF, Pulmonary Fibrosis, n-acetylcysteine, NAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally three times daily or matched placebo for 24 months.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participant and site personnel will not know which study treatment the participant is receiving.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
600 mg oral N-acetylcysteine (NAC) three times daily for 24 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet three times daily for 24 months.
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Other Intervention Name(s)
NAC
Intervention Description
600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral placebo tablet three times daily for 24 months.
Primary Outcome Measure Information:
Title
Time to one of the following composite endpoint criteria: 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause.
Description
This is a composite endpoint of time to 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Time to one of the following composite criteria: 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.
Description
This is a composite endpoint of time to 10% relative decline in FVC % predicted, based on the global lung initiative (GLI) reference equation, first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Time Frame
24 months
Title
Time to death from any cause
Time Frame
24 months
Title
Time to first respiratory hospitalization
Description
Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Time Frame
24 months
Title
Time to 10% relative decline in FVC
Time Frame
24 months
Title
Time to lung transplant
Time Frame
24 months
Title
Time to 10% relative decline in FVC %predicted
Time Frame
24 months
Title
Time to first all-cause hospitalization
Time Frame
24 months
Title
Annualized rate of respiratory hospitalizations
Time Frame
24 months
Title
Annualized rate of non-elective, all-cause hospitalizations
Time Frame
24 months
Title
Proportion of participants undergoing lung transplant during follow-up
Time Frame
24 months
Title
Change in FVC from randomization at 12 months
Time Frame
12 months
Title
Change in FVC % predicted from randomization at 12 months
Time Frame
12 months
Title
Change in FVC from randomization at 24 months
Time Frame
24 months
Title
Change in FVC % predicted from randomization at 24 months
Time Frame
24 months
Title
Change in diffusing capacity of the lung for carbon monoxide (DLCO) uncorrected for hemoglobin from randomization at 12 months
Time Frame
12 months
Title
Change in DLCO from randomization at 24 months
Time Frame
24 months
Title
Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 12 months.
Time Frame
12 months
Title
Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 12 months.
Time Frame
12 months
Title
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 12 months.
Time Frame
12 months
Title
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 12 months.
Time Frame
12 months
Title
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 12 months.
Time Frame
12 months
Title
Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 24 months
Time Frame
24 months
Title
Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 24 months
Time Frame
24 months
Title
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 24 months
Time Frame
24 months
Title
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 24 months
Time Frame
24 months
Title
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 24 months
Time Frame
24 months
Title
Proportion of participants with and number of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and unanticipated problems
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 40 years of age Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator Signed informed consent If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit Confirmed rs3570920 TT TOLLIP genotype Exclusion Criteria: Pregnancy or planning to become pregnant Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year during study participation Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer Supplemental or prescribed NAC therapy within 60 days of enrollment Listed for lung transplantation at the time of screening History of lung cancer Inability to perform spirometry Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1 Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betsy Peters
Phone
646-962-2742
Email
elp2018@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando J Martinez, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Imre Noth, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Flaherty, MS, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cathie Spino, ScD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Chaudhary, MD
Phone
520-626-6114
Email
sachin@deptofmed.arizona.edu
First Name & Middle Initial & Last Name & Degree
Heidi Erickson
Phone
520-626-5287
Email
herickso@arizona.edu
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toby Maher, MD
Phone
323-865-9854
Email
toby.maher@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Lynn Fukushima, RN
Phone
323-409-5383
Email
lynn.fukushima@med.usc.edu
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Mooney, MD, MS
Phone
650-725-9729
Email
jmooney1@stanford.edu
First Name & Middle Initial & Last Name & Degree
Susan Jacobs, RN, MS
Phone
650-735-8083
Email
ssjpulm@stanford.edu
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Lee, MD
Email
JOYCE.LEE@CUANSCHUTZ.EDU
First Name & Middle Initial & Last Name & Degree
Haylie Lengel
Phone
970-376-8303
Email
haylie.lengel@cuanschutz.edu
Facility Name
Piedmont Healthcare
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Case, MD
Phone
770-948-6041
Email
amy.case@piedmont.org
First Name & Middle Initial & Last Name & Degree
Stacy Beasley
Phone
770-745-1404
Email
Stacy.Beasley@piedmont.org
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Strek
Phone
773-702-1796
Email
mstrek@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Spring Maleckar
Phone
773-834-4053
Email
smaleckar@medicine.bsd.uchicago.edu
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Dilling, MD
Phone
708-216-5404
Email
DDILLIN@lumc.edu
First Name & Middle Initial & Last Name & Degree
Josefina Corral
Phone
708-216-5744
Email
jcorral@luc.edu
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Boente, MD
Phone
317-278-0064
Email
rboente@iu.edu
First Name & Middle Initial & Last Name & Degree
Meghan Willig
Phone
317-962-3183
Email
mwillig@IUHealth.org
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hamblin, MD
Phone
913-588-6045
Email
mhamblin@kumc.edu
First Name & Middle Initial & Last Name & Degree
Kimberly Lovell
Phone
913-588-6067
Email
klovell@kumc.edu
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph A Lasky, MD
Phone
504-988-4040
Email
jlasky@tulane.edu
First Name & Middle Initial & Last Name & Degree
Sandy Ditta, BSN
Phone
504-988-4040
Email
sditta@tulane.edu
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
617-726-1721
Email
SBMONTESI@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Caroline Fromson
Phone
617-643-3260
Email
CFROMSON@MGH.HARVARD.EDU
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Belloli, MD
Phone
734-647-6477
Email
bellolie@umich.edu
First Name & Middle Initial & Last Name & Degree
Candace Flaherty
Email
cflah@med.umich.edu
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Kim, MD
Phone
612-624-0999
Email
kimxx015@umn.edu
First Name & Middle Initial & Last Name & Degree
Mandi DeGrote
Phone
612-626-7609
Email
carl1032@umn.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Limper, MD
Phone
507-284-4162
Email
Limper.Andrew@mayo.edu
First Name & Middle Initial & Last Name & Degree
Shannon Daley
Phone
507-293-0637
Email
Daley.Shannon@mayo.edu
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Kaner, MD
Phone
646-962-2333
Email
rkaner@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Alicia Morris
Phone
646-962-2741
Email
ajm2017@med.cornell.edu
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Kottman, MD
Phone
585-275-4861
Email
matt_kottmann@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Karen Clark, LPN
Phone
585-397-6516
Email
karen_clark@urmc.rochester.edu
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitin Bhatt, MD
Phone
614-293-4925
Email
nitin.bhatt@osumc.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Hood
Phone
614-293-3351
Email
benjamin.hood2@osumc.edu
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Criner, MD
Phone
215-707-8113
Email
Gerard.Criner@tuhs.temple.edu
First Name & Middle Initial & Last Name & Degree
Francis McGonagle
Phone
215-707-2682
Email
Francine.McGonagle@tuhs.temple.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy M Whelan, MD
Phone
843-792-1414
Email
whelant@musc.edu
First Name & Middle Initial & Last Name & Degree
Ashley Warden
Email
jonesash@musc.edu
Facility Name
Lisa Lancaster
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Lancaster, MD
Phone
615-322-0476
Email
lisa.lancaster@vumc.org
First Name & Middle Initial & Last Name & Degree
James Del Greco
Phone
615-322-0476
Email
james.del.greco@vumc.org
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Newton, MD
Phone
214-645-6493
Email
Chad.Newton@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Rhoda Annoh Gordon
Phone
214-645-7108
Email
rhoda.annohgordon@utsouthwestern.edu
Facility Name
University of Texas Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anoop Nambiar, MD
Phone
210-617-5256
Email
Nambiar@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Hilda Pomroy
Phone
210-450-9022
Email
pomroy@uthscsa.edu
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Beth Scholand, MD
Phone
801-581-5811
Email
marybeth.scholand@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Chloe Kirkpatrick
Phone
801-581-5811
Email
chloe.kirkpatrick@hsc.utah.edu
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tessy Paul, MD
Phone
434-243-2398
Email
TKP4N@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Katie Brown-Steinke
Phone
434-924-0749
Email
KB8S@hscmail.mcc.virginia.edu
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganesh Raghu, MD
Phone
206-598-0440
Email
graghu@uw.edu
First Name & Middle Initial & Last Name & Degree
Reba Blissel
Email
blissr@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with NHLBI data sharing policies.
IPD Sharing Time Frame
3 years after the end of the study or 2 years after the main paper reporting the results of the trial, whichever comes first.
IPD Sharing Access Criteria
Data will be shared through the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/home/

Learn more about this trial

Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial

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