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A Phase 3 Study of CS-8958 (Prophylaxis of Single Administration) - A randomized, double-blind, placebo-controlled study to evaluate the efficacy of single dose administration for the prevention of influenza virus infection -

A Phase 3 Study of CS-8958 (Prophylaxis of Single Administration)

803

Most of the participants were a parent of the index patient. Of the 687 index patients, 670 were infected with the influenza A(H3N2) virus. Among the participants, 37.8% were vaccinated in the 2014-2015 influenza season.

A total of 803 subjects (267 subjects in the CS-8958 40 mg single administration group, 269 subjects in the CS-8958 20 mg once daily for 2 days administration group and 171 subjects in the placebo group) were enrolled into the study. 801 subjects completed the study (267 subjects in the CS-8958 40 mg single administration group, 269 subjects in the CS-8958 20 mg once daily for 2 days administration group and 265 subjects in the placebo group).

The incidence of adverse events was similar for the CS-8958 40 mg single administration group, CS-8958 20 mg once daily for 2 days administration group, and placebo groups at 11.6% (31/267), 11.2% (30/269), and 12.1% (32/265), respectively. All of the adverse events were regarded as being mild or moderate in severity. No deaths, serious adverse events, or abnormal behavior were reported.

The proportion of subjects with clinical influenza were 4.5% (12/267), 4.5% (12/269), and 12.1% (32/265) in the CS-8958 40 mg single administration group, CS-8958 20 mg once daily for 2 days administration group and placebo group, respectively (P = .01). The relative risk reduction was 62.8% (95% CI, 29.3%-80.4%) and 63.1% (95% CI, 29.8%-80.5%), respectively.

The proportion of subjects with symptomatic influenza were 8.6% (23/267), 9.3% (25/269), and 18.9% (50/265) in the CS-8958 40 mg single administration group, CS-8958 20 mg once daily for 2 days administration group and placebo group, respectively (P = .01).

Single dose of inhaled CS-8958 40 mg was effective as post-exposure prophylaxis to prevent the development of influenza through household contacts, as was the inhalation of 20 mg of CS-8958 once daily for 2 days. Adverse events in CS-8958 40 mg single-dose group did not differ significantly from those in the CS-8958 20 mg once daily for 2 days administration group and placebo-group. No abnormal behaviors were observed, and there were no other major safety issues.

April. 26, 2016

https://academic.oup.com/cid/article/63/3/330/2566601

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. 17, 2014

Interventional

Multicenter, randomized, double-blind, 3-parallel-group, placebo-controlled

prevention purpose

3

Household contact of a patient with influenza virus infection
Body temperature (axillary) at informed consent =< 36.9 degrees C
No influenza symptoms

Persons who are unable to cohabit with an index patient
Persons who cannot start study treatment within 48 hours after the initial onset of any influenza symptom in the index patient
Persons receiving corticosteroids or immunosuppressants
Persons who have a history of hypersensitivity to a neuraminidase inhibitor

Both

Postexposure prophylaxis of 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 inhaled administration of CS-8958 40 mg, or inhaled administration of CS-8958 20 mg once daily for 2 days

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

safety
efficacy
Proportion of subjects with laboratory-confirmed influenza virus infection and influenza symptoms

safety
efficacy
Proportion of subjects with laboratory-confirmed influenza virus infection

-

Sept. 11, 2014