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

Who is this study for? Patients diagnosed with idiopathic pulmonary fibrosis who have the TOLLIP rs3750920 TT genotype
What treatments are being studied? N-acetyl cysteine
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: No
View:

• ≥ 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

Locations
United States
Arizona
University of Arizona
Recruiting
Tucson
California
University of California, Los Angeles
Not yet recruiting
Los Angeles
University of Southern California
Not yet recruiting
Los Angeles
Stanford University
Recruiting
Stanford
Colorado
University of Colorado
Not yet recruiting
Aurora
Georgia
Piedmont Healthcare
Recruiting
Austell
Illinois
University of Chicago
Recruiting
Chicago
Loyola University
Not yet recruiting
Maywood
Indiana
Indiana University
Recruiting
Indianapolis
Kansas
University of Kansas Medical Center
Recruiting
Kansas City
Louisiana
Tulane University
Recruiting
New Orleans
Massachusetts
Massachusetts General Hospital
Recruiting
Boston
Michigan
University of Michigan
Recruiting
Ann Arbor
Minnesota
University of Minnesota
Recruiting
Minneapolis
Mayo Clinic
Recruiting
Rochester
New York
Weill Cornell Medicine
Recruiting
New York
University of Rochester
Recruiting
Rochester
Ohio
Ohio State University
Recruiting
Columbus
Pennsylvania
Temple University
Recruiting
Philadelphia
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Tennessee
Lisa Lancaster
Recruiting
Nashville
Texas
University of Texas Southwestern
Recruiting
Dallas
University of Texas Health San Antonio
Recruiting
San Antonio
Utah
University of Utah Health
Recruiting
Salt Lake City
Virginia
University of Virginia
Recruiting
Charlottesville
Washington
University of Washington
Recruiting
Seattle
Contact Information
Primary
Betsy Peters
elp2018@med.cornell.edu
646-962-2742
Time Frame
Start Date: December 17, 2020
Estimated Completion Date: September 15, 2025
Participants
Target number of participants: 200
Treatments
Experimental: N-acetylcysteine
600 mg oral N-acetylcysteine (NAC) three times daily for 24 months.
Placebo Comparator: Placebo
Placebo tablet three times daily for 24 months.
Authors
Imre Noth, Fernando J Martinez, Kevin Flaherty, Cathie Spino
Sponsors
Collaborators: University of Michigan, National Heart, Lung, and Blood Institute (NHLBI), University of Washington, Three Lakes Foundation, Pulmonary Fibrosis Foundation, University of Virginia
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov

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