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The Utility of the FIB-4 Index in Patients with Progressive Fibrosing Interstitial Lung Diseases: A Retrospective Cohort Study

The Utility of the FIB-4 Index in Patients with Progressive Fibrosing Interstitial Lung Diseases: A Retrospective Cohort Study - The Utility of the FIB-4 Index in Patients with PF-ILD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000060770
Enrollment
50
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive fibrosing interstitial lung disease

Interventions

None listed

Sponsors

Yamanashi Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
delta FVC from baseline (ml/year) (liner mixed model)

Secondary

MeasureTime frame
Time to first acute exacerbation or death Correlation between KL-6 and FIB-4 index (Spearman)

Countries

Japan

Contacts

Public ContactYosuke Fukuda

Yamanashi Red Cross Hospital Department of Medicine, Division of Respiratory Medicine

yosukefukuda.showa@gmail.com0555-72-2222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026