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 Cornell MedicineUniversity of VirginiaUniversity of MichiganUniversity of Michigan
Agency Class

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

OtherOtherOtherOtherOtherNIHOther
Overall Status 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.

Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

Joshua Mooney, MD, MS

jmooney1@stanford.edu

650-725-9729

Piedmont Healthcare, Austell, Georgia

Status

Not yet recruiting

Address

Piedmont Healthcare

Austell, Georgia, 30106

Site Contact

Amy Case, MD

amy.case@piedmont.org

770-948-6041

Tulane University, New Orleans, Louisiana

Status

Recruiting

Address

Tulane University

New Orleans, Louisiana, 70112

Site Contact

Joseph A Lasky, MD

jlasky@tulane.edu

504-988-4040

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Elizabeth Belloli, MD

bellolie@umich.edu

734-647-6477

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Matthew Kottman, MD

matt_kottmann@urmc.rochester.edu

585-275-4861

Temple University, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19140

Site Contact

Gerard Criner, MD

Gerard.Criner@tuhs.temple.edu

215-707-8113

Medical University of South Carolina, Charleston, South Carolina

Status

Not yet recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Timothy M Whelan, MD

whelant@musc.edu

843-792-1414

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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