An observational study to determine the relationship between blood concentrations of Nintedanib and the safety of the drug in the real world.

An observational study to analyze the pharmacokinetics of Nintedanib and to elucidate the relationship between the safety and efficacy of the drug in the real world. - An observational study to elucidate the relationship between the pharmacokinetics of Nintedanib and the safety and efficacy of the drug.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052260

Enrollment

100

Registered

2023-09-20

Start date

2022-08-05

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

interstitial pneumonia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are eligible: 1. Patients who have been continuously taking Nintedanib for at least 3 days. 2. Patients who have provided their consent to participate in this study by signing a consent form themselves or through a proxy.

Exclusion criteria

Exclusion criteria: 1. Individuals deemed unsuitable by the principal investigator and co-investigators. 2. Those who were unable to provide consent for this research.

Design outcomes

Primary

Measure	Time frame
The association between blood levels of Nintedanib and the occurrence of adverse effects.	—

Countries

Japan

Contacts

Public ContactHideki Yasui

Hamamatsu University Hospital Division of Respiratory Medicine

yasui@hama-med.ac.jp053-435-2263

Outcome results