Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060770) titled 'The Utility of the FIB-4 Index in Patients with Progressive Fibrosing Interstitial Lung Diseases: A Retrospective Cohort Study' on April 1.

Study Type: Observational

Primary Sponsor: Institute - Yamanashi Red Cross Hospital

Condition: Condition - Progressive fibrosing interstitial lung disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the utility of the FIB-4 Index as a prognostic factor for progressive fibrosing interstitial lung disease Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients and study period: We included patients with progressive fibrosing interstitial lung disease (PF-ILD) who had received nintedanib at Yamanashi Red Cross Hospital between September 1, 2015 and February 28, 2026.

Baseline laboratory data: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count were required to be measured within 30 days before or after nintedanib initiation; when multiple measurements were available within this window, the value closest to the initiation date was used.

Follow-up availability: Patients were required to have ascertainable follow-up after nintedanib initiation, with either the date of death or the date of last confirmed clinical contact documented.

Consent: Informed consent was obtained using an opt-out procedure. Key exclusion criteria - Baseline laboratory data: AST, ALT, and platelet count were not measured within 30 days of nintedanib initiation. AST, ALT, and platelet count obtained within 30 days of nintedanib initiation were judged by the treating clinician to reflect an acute illness (i.e., not representative of baseline status).

Drugs: Use of any antifibrotic agent within the 90 days prior to cohort entry.

Consent: Informed consent could not be obtained via the opt-out procedure. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 27 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069531

Disclaimer: Curated by HT Syndication.