Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062558) titled 'Real-World Experience and Clinical Course of Antifibrotic Therapy: A Prospective Observational Study' on Aug. 15.
Study Type:
Observational
Primary Sponsor:
Institute - Hamamatsu University School of Medicine
Condition:
Condition - fibrotic interstitial lung disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To prospectively investigate the clinical course of patients with fibrotic interstitial lung disease initiating nerandomilast in a multicenter setting.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 20 years or older
2. Patients who have provided written informed consent for participation in this study by signing the consent form
Key exclusion criteria - 1. Patients with progressive or active malignant tumors
2. Women who are pregnant or who may be pregnant
3. Women who are breastfeeding
4. Patients deemed unsuitable for participation by a sub-investigator
Target Size - 300
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 08 Month 10 Day
Date of IRB - 2026 Year 08 Month 15 Day
Anticipated trial start date - 2026 Year 08 Month 15 Day
Last follow-up date - 2031 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071610
Disclaimer: Curated by HT Syndication.
