This study is currently not recruiting participants.

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

R
Ryan Boente

Primary Investigator

Not Recruiting
40 years or above
All
Phase 3
200 participants needed
1 Location

Brief description of study

The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standardwith matched placebo plus standard of care in patients diagnosed with idiopathiculmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will comparehe time to a composite endpoint of relative decline in lung function [10% relative declined vital capacity (FVC), first respiratory hospitalization, lung transplantation, oruse mortality]
The secondary objectives will be to examine the effect of NAC on the components of they composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.

Detailed description of study

This is a multi-center, randomized, double-blind, placebo-controlled trial of NAC or placebobout 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 byble 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 willve 600 mg NAC orally or matched placebo to take three times daily for 24 months.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Idiopathic Pulmonary Fibrosis
  • Age: 40 years or above
  • Gender: All

Inclusion Criteria:
  • ≥ 40 years of age
  • Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrollingvestigator
  • Signed informed consent
  • If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks priorvisit
  • Confirmed rs3570920 TT TOLLIP genotype
Exclusion Criteria:
  • Pregnancy or planning to become pregnant
  • Women of childbearing potential not willing to remain abstinent (refrain fromheterosexual intercourse) or use two adequate methods of contraception, including athod with a failure rate of <1% per year during study participation
  • Significant medical, surgical or psychiatric illness that in the opinion of thevestigator would affect subject safety, including liver and renal failure
  • Receipt of an investigational drug or biological agent within the previous 4 weeks ofhe 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 functiondex (GLI) equation at Visit 1
  • Active respiratory infection requiring treatment with antibiotics within 4 weeks ofVisit 1

Updated on 13 Dec 2024. Study ID: 19-12021232

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