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Report for Clinical Trial NCT04300920

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT04300920 Idiopathic Pulmonary Fibrosis
MeSH:Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

2 Interventions

Name: N-acetyl cysteine

Description: 600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.
Type: Drug
Group Labels: 1

N-acetylcysteine

Name: Placebo

Description: Matching oral placebo tablet three times daily for 24 months.
Type: Drug
Group Labels: 1

Placebo


Primary Outcomes

Description: This is a composite endpoint of time to 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.

Measure: Time to one of the following composite endpoint criteria: 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause.

Time: 24 months

Secondary Outcomes

Description: This is a composite endpoint of time to 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.

Measure: Time to one of the following composite criteria: 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.

Time: 24 months

Measure: Time to death from any cause

Time: 24 months

Description: Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.

Measure: Time to first respiratory hospitalization

Time: 24 months

Measure: Time to 10% relative decline in FVC

Time: 24 months

Measure: Time to lung transplant

Time: 24 months

Measure: Time to 10% relative decline in FVC %predicted

Time: 24 months

Measure: Time to first all-cause hospitalization

Time: 24 months

Measure: Annualized rate of respiratory hospitalizations

Time: 24 months

Measure: Annualized rate of non-elective, all-cause hospitalizations

Time: 24 months

Measure: Proportion of participants undergoing lung transplant during follow-up

Time: 24 months

Measure: Change in FVC from randomization at 12 months

Time: 12 months

Measure: Change in FVC % predicted from randomization at 12 months

Time: 12 months

Measure: Change in FVC from randomization at 24 months

Time: 24 months

Measure: Change in FVC % predicted from randomization at 24 months

Time: 24 months

Measure: Change in diffusing capacity of the lung for carbon monoxide (DLCO) corrected for hemoglobin from randomization at 12 months

Time: 12 months

Measure: Change in DLCO from randomization at 24 months

Time: 24 months

Measure: Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 12 months.

Time: 12 months

Measure: Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 12 months.

Time: 12 months

Measure: Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 12 months.

Time: 12 months

Measure: Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 12 months.

Time: 12 months

Measure: Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 12 months.

Time: 12 months

Measure: Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 24 months

Time: 24 months

Measure: Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 24 months

Time: 24 months

Measure: Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 24 months

Time: 24 months

Measure: Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 24 months

Time: 24 months

Measure: Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 24 months

Time: 24 months

Measure: Proportion of participants with and number of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and unanticipated problems

Time: 24 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 rs3570920

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 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 Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis 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.


2 rs3750920

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

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 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 Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis 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.



HPO Nodes


HPO: