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

Phase 2

Recruiting

• Conditions: progressive fibrosing interstitial lung disease; interstitial lung disease; D017563

• Registration Number: JPRN-jRCTs031220648
• Lead Sponsor: rushiyama Hirokazu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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.
7. Those who do not want to be treated with nintedanib at the time of study entry.

Exclusion Criteria

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.
11. Those who are pregnant or possibly pregnant.
12. Those deemed by the principal investigator or subinvestigator to be inappropriate to participate in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of Grade 2 or higher adverse events

Secondary Outcome Measures

Name	Time	Method
1. Percent change in FVC decrease (ml/year)<br>2. Percent Change in DLco Predicted Decline (%/year)<br>3. Changes in various symptoms using patient questionnaires<br>4. Changes in serum transaminases and serum creatinine<br>5. Frequency of Grade 2 or higher side effects<br>6. Evaluation of interstitial lung disease status by the physician.