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Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04300920
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Fernando J Martinez, MDImre Noth, MDKevin Flaherty, MS, MDCathie Spino, ScD
Principal Investigator Affiliation Weill Medical College of Cornell UniversityUniversity of VirginiaUniversity of MichiganUniversity of Michigan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Idiopathic Pulmonary Fibrosis
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Drug: - N-acetyl cysteine

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

Drug: - Placebo

Matching oral placebo tablet three times daily for 24 months.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona, Tucson, Arizona

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University of Arizona

Tucson, Arizona, 85724

University of Southern California, Los Angeles, California

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University of Southern California

Los Angeles, California, 90033

Stanford University, Stanford, California

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Stanford University

Stanford, California, 94305

University of Colorado, Aurora, Colorado

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University of Colorado

Aurora, Colorado, 80045

Piedmont Healthcare, Austell, Georgia

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Piedmont Healthcare

Austell, Georgia, 30106

University of Chicago, Chicago, Illinois

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University of Chicago

Chicago, Illinois, 60637

Loyola University, Maywood, Illinois

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Loyola University

Maywood, Illinois, 60153

Indiana University, Indianapolis, Indiana

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Indiana University

Indianapolis, Indiana, 46202

University of Kansas Medical Center, Kansas City, Kansas

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University of Kansas Medical Center

Kansas City, Kansas, 66160

Tulane University, New Orleans, Louisiana

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Tulane University

New Orleans, Louisiana, 70112

Massachusetts General Hospital, Boston, Massachusetts

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Massachusetts General Hospital

Boston, Massachusetts, 02114

University of Michigan, Ann Arbor, Michigan

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University of Michigan

Ann Arbor, Michigan, 48109

University of Minnesota, Minneapolis, Minnesota

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University of Minnesota

Minneapolis, Minnesota, 55455

Mayo Clinic, Rochester, Minnesota

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Mayo Clinic

Rochester, Minnesota, 55905

Weill Cornell Medicine, New York, New York

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Weill Cornell Medicine

New York, New York, 10016

University of Rochester, Rochester, New York

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University of Rochester

Rochester, New York, 14642

Ohio State University, Columbus, Ohio

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Ohio State University

Columbus, Ohio, 43221

Temple University, Philadelphia, Pennsylvania

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Temple University

Philadelphia, Pennsylvania, 19140

Medical University of South Carolina, Charleston, South Carolina

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Medical University of South Carolina

Charleston, South Carolina, 29425

Lisa Lancaster, Nashville, Tennessee

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Lisa Lancaster

Nashville, Tennessee, 37204

University of Texas Southwestern, Dallas, Texas

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University of Texas Southwestern

Dallas, Texas, 75390

University of Texas Health San Antonio, San Antonio, Texas

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University of Texas Health San Antonio

San Antonio, Texas, 78229

University of Utah Health, Salt Lake City, Utah

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University of Utah Health

Salt Lake City, Utah, 84108

University of Virginia, Charlottesville, Virginia

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University of Virginia

Charlottesville, Virginia, 22908

University of Washington, Seattle, Washington

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University of Washington

Seattle, Washington, 98195

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