臨床研究等提出・公開システム

Date of registration	Oct. 06, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221607

Scientific Title	A Phase 3 Study of CS-8958 (Postexposure Prophylaxis 2011) - A randamized, double-blind, placebo-controlled study to confirm the efficacy in the prevention of influenza virus infection -
Public Title	A Phase 3 Study of CS-8958 (Postexposure Prophylaxis 2011)

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO Co.Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		1500
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, 3-parallel-group, double-blind, placebo-controlled
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Household contact of a patient with influenza virus infection Body temperature (axillary) at informed consent < 36.9°C No influenza symptoms
	Exclusion Criteria	Subjects with severe renal impairment or undergoing hemodialysis Subjects receiving corticosteroids or immunosuppressants
	Minimum Age	10age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Postexposure prophylaxis of influenza A or B virus infection
Intervention(s)		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 : Inhalation control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Inhalation
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Proportion of subjects with laboratory-confirmed influenza virus infection and influenza symptoms
Secondary Outcome		Proportion of subjects with laboratory-confirmed influenza virus infection

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-111647
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Sept. 19, 2014	Detail	Changes
7	Sept. 18, 2014	Detail	Changes
6	May. 15, 2013	Detail	Changes
5	May. 15, 2013	Detail	Changes
4	May. 09, 2012	Detail	Changes
3	May. 09, 2012	Detail	Changes
2	Oct. 06, 2011	Detail	Changes
1	Oct. 06, 2011	Detail

List of change history