臨床研究等提出・公開システム

CS-8958 Phase 3 study - A randomized, single-blind, placebo-controlled study of nebulized CS-8958 in the treatment of influenza virus infection -

A Phase 3 Study of nebulized CS-8958 (Treatment of influenza)

534

Of all 534 subjects, 520 (97%; 262 [98%] and 258 [97%] cases in the CS-8958 group and in the placebo group, respectively) were infected with influenza A(H3N2) virus. Among all subjects, 145 (27%) had received the 2016/2017 seasonal influenza vaccination. The proportion of subjects with high-risk factors was 7.1% (38/534).

A total of 534 subjects (268 subjects in the CS-8958 group and 266 subjects in the placebo group) were enrolled into the study. The study was completed by 526 subjects (267 subjects in the CS-8958 group and 259 subjects in the placebo group).

In the safety analysis set (534 subjects), the incidence of adverse events was 13% (36/268) in the CS-8958 group and 11% (28/266) in the placebo group. No deaths, serious adverse events, or abnormal behavior were reported.

The median duration of influenza illness (95% CI) was 55.3 (48.9 to 68.8) h in the CS-8958 group and 73.6 (67.8 to 84.3) h in the placebo-treated group, with a difference (95% CI) of-18.3 (-23.6 to-3.8) h.

The median time to normothermia (95% CI) was 36.4 (33.0-41.3) h in the CS-8958 group and 51.4 (45.7-57.8) h in the placebo-treated group, with a difference (95% CI) of -15.0 (-18.6 to-7.9) h.

CS-8958 nebulizer inhaler 160 mg was effective in adults and children aged 10 years and older with influenza A or B virus infection. The incidence and content of adverse events did not differ between CS-8958 and placebo-treated subjects, and there were no safety concerns associated with a single inhaled dose of CS-8958 nebulizer 160mg.

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

Nov. 29, 2016

Interventional

Multicenter, randomized, single-blind, 2-parallel-group, placebo-controlled study

treatment purpose

3

Tested positive for influenza A or B by the rapid diagnostic test
Body temperature (axillary) at informed consent >= 37.5 degrees
Within 36 hours of the onset of influenza symptoms at informed consent

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

efficacy
safety
Time for body temperature returned to normal (=<36.9 degrees)

-

Oct. 14, 2016