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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 -

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

173

Of all 173 subjects, 161 (93%) were infected with influenza A(H3N2) virus. Among all subjects, 61 (35%) had received the 2016/2017 seasonal influenza vaccination. The proportion of subjects under 3 years of age was 16% (27/173).

A total of 173 subjects were enrolled into the study. The study was completed by 170 subjects.

In the safety analysis set (173 subjects), the incidence of adverse events was 20% (35/173). No deaths, serious adverse events were reported.

The median duration of influenza illness (95% CI) was 49.0(43.0-61.0)h.

The median time to normothermia (95% CI) was 31.1(25.8-33.7)h.

CS-8958 nebulizer inhaler 160 mg was confirmed to have some efficacy in children younger than 10 years with influenza A or B virus infection. There were no notable safety concerns associated with a single inhaled dose of CS-8958 nebulizer 160 mg.

Yes

Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Documents: - Study Protocol - Statistical Analysis Plan - Clinical Study Report Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co., Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Dec. 03, 2016

Interventional

Multicenter, open-labeled study

treatment purpose

3

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

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

Both

Influenza A or B virus infection

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 material : Single inhalation of nebulized CS-8958 160 mg

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
efficacy
confirmatory
Time to alleviation of influenza illness

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

-

Oct. 14, 2016