An exploratory study of the safety and efficacy of disulfiram in progressive fibrosing interstitial lung disease

rushiyama Hirokazu0 sites10 target enrollmentFebruary 20, 2023

Overview

No summary available.

Registry

who.int

Start Date

February 20, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

rushiyama Hirokazu

•1\. Patients who have been diagnosed with interstitial lung disease and are being managed appropriately but who, within 24 months of the date of consent, meet at least one of the following criteria.
•\- A relative decline in the %FVC of at least 10% of the predicted value.
•\- A relative decline in the %FVC of 5% to less than 10% of the predicted value and worsening of respiratory symptoms.
•\- A relative decline in the %FVC of 5% to less than 10% of the predicted value and an increased extent of fibrosis on chest imaging.
•\- Worsening of respiratory symptoms and increased fibrotic changes on chest imaging.
•2\. Age: Those who are between 18 and less than 80 years old at the time of obtaining consent.
•3\. Gender: Any gender.
•4\. Those with respiratory function test results (FVC, DLco) performed at least 3 months prior to obtaining consent.
•5\. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study.
•6\. Those who can make outpatient visits in accordance with the research implementation schedule.

•1\. Those with resting SpO2 less than 95%.
•2\. Those with a modified MRC breathlessness score of 3 or higher.
•3\. Those with FVC less than 60% of predicted value.
•4\. Those with Hb\-corrected DLco less than 60% of predicted value.
•5\. Those with active malignant tumor.
•6\. Those with serious cardiac, renal or hepatic disorders (judged with reference to Grade 3 of the JCOG version of CTCAE version 5\.0\).
•7\. Those with seizure disorder such as epilepsy or a history of epilepsy.
•8\. Those with cerebral organic disorders.
•9\. Those who are unable to abstain from alcohol or discontinue alcohol\-containing drugs or cosmetics while participating in the study.
•10\. Those with hypersensitivity to disulfiram.