Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062969) titled 'A Prospective Observational Study on Clinical Outcomes Following the Introduction of Nelandomirast in
Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)' on Sept. 17.
Study Type:
Observational
Primary Sponsor:
Institute - National Hospital Organization Ibarakihigashi National Hospital
Condition:
Condition - Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate changes over time in lung function and biomarkers following the initiation of nelandomirast in Japanese patients with IPF/PPF
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Men and women aged 20 years or older (at the time of obtaining consent)
2. Patients who meet the diagnostic criteria for IPF (2022 ATS/ERS/JRS/ALAT guidelines) or PPF (2022 ATS/ERS/JRS/ALAT guidelines)
3. Patients who can obtain written consent
Key exclusion criteria - 1. Patients with severe hepatic impairment (Child-Pugh Class C)
2. Patients with a history of severe hypersensitivity to PDE4 inhibitors
3. Patients whom the attending physician deems unsuitable for enrollment in this study
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 09 Month 17 Day
Last follow-up date - 2030 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072066
Disclaimer: Curated by HT Syndication.
