Exploratory study of blood biomarkers to predict the therapeutic effect of nintedanib in idiopathic pulmonary fibrosis (IPF)

Exploratory study of blood biomarkers to predict the therapeutic effect of nintedanib in idiopathic pulmonary fibrosis (IPF) - OFBIO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036457

Enrollment

100

Registered

2019-05-01

Start date

2019-04-01

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

idiopathic pulmonary fibrosis (IPF)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Patients diagnosed with IPF according to 2018 ATS / ERS / JRS / ALAT guidelines 2 Patients over 20 years old 3 Patients with %FVC less than 80% at entry time or patients with decrease of %FVC more than 3% in the past 6 months

Exclusion criteria

Exclusion criteria: 1 Patients who can not get consent 2 patients whom the doctor in charge deems inappropriate 3 Patients with acute exacerbation at time 4 Patients with malignancy 5 Patients scheduled for surgery within 6 months 6 Patients with severe liver disorder (Child-Pugh B or more) 7 Patients whose prognosis is predicted to be less than 6 months

Design outcomes

Primary

Measure	Time frame
Decrease of % FVC	—

Secondary

Measure	Time frame
Symptoms Treatment continuation rate Overall survival Adverse event	—

Countries

Japan

Contacts

Public ContactMITSUHIRO ABE

Chiba University Hospital Respiratory medicine

mthrsgnm@chiba-u.jp043-226-2576

Outcome results