Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Idiopathic Pulmonary Fibrosis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The participant and site personnel will not know which study treatment the participant is receiving.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
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., pi...
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.
Tracking Information
- NCT #
- NCT04300920
- Collaborators
- University of Virginia
- University of Michigan
- Pulmonary Fibrosis Foundation
- University of Washington
- National Heart, Lung, and Blood Institute (NHLBI)
- Three Lakes Foundation
- Investigators
- Principal Investigator: Fernando J Martinez, MD Weill Medical College of Cornell University Principal Investigator: Imre Noth, MD University of Virginia Principal Investigator: Kevin Flaherty, MS, MD University of Michigan Principal Investigator: Cathie Spino, ScD University of Michigan
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