Status:
ACTIVE_NOT_RECRUITING
Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
Lead Sponsor:
Fernando J Martinez
Collaborating Sponsors:
University of Virginia
University of Michigan
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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...
Detailed 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 rand...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2026
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04300920
Start Date
December 17 2020
End Date
February 27 2026
Last Update
May 29 2025
Active Locations (25)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of Southern California
Los Angeles, California, United States, 90033
3
Stanford University
Stanford, California, United States, 94305
4
University of Colorado
Aurora, Colorado, United States, 80045