The special drug use surveillance of INAVIR for inhalation suspension set (Safety evaluation in pediatric patients under five years old)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080224937

Enrollment

1000

Registered

2019-11-06

Start date

2019-11-01

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

Influenza virus infection

Interventions

investigational material(s) Generic name etc : INAVIR for inhalation suspension set INN of investigational material : laninamivir Therapeutic category code : 625 Anti-virus agents Dosage and Administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients had not been treated with INAVIR for inhalation suspension set in the same influenza season. 2) Children under five years old 3) Patients had been diagnosed by a participating physician as being influenza virus infection positive based on a rapid diagnosis kit. 4) Patients were not suspected of primary or secondary infection with pathogenic microorganisms(viruses/bacteria)other than the influenza virus. 5) Patients obtained written informed consent from their guardians.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
safety Incidence of adverse drug reactions	—

Secondary

Measure	Time frame
efficacy Duration to fever resolution Duration to relief from influenza symptoms	—

Countries

Japan

Outcome results

None listed

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