A Phase 3 Study of nebulized CS-8958 (Pediatric Patients < 10 years of age)

CS-8958 Phase 3 study in Pediatric Patients < 10 years of age - A open-labeled study of nebulized CS-8958 in the treatment of influenza virus infection -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223343

Enrollment

150

Registered

2016-10-06

Start date

2016-12-03

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 A or B virus infection

Interventions

investigational material(s) Generic name etc : CS-8958 INN of investigational material : laninamivir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Tested positive for influenza A or B by the rapid diagnostic test Body temperature (axillary) at informed consent >= 38.0 degrees Within 36 hours of the onset of influenza symptoms at informed consent Judged to be able to take a nebulized treatment

Exclusion criteria

Exclusion criteria: Suspected of having infection by bacteria species and/or other virus (pneumonia, bronchitis, otitis, sinusitis, etc.; including secondary infection) within 1 week before informed consent History of influenza pneumonia Assessed to be ineligible by the investigators, including those with serious complications

Design outcomes

Primary

Measure	Time frame
safety efficacy confirmatory Time to alleviation of influenza illness	—

Secondary

Measure	Time frame
safety efficacy Time to improvement of cough and nasal symptom Time for body temperature returned to normal	—

Countries

Japan

Outcome results

None listed

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