臨床研究等提出・公開システム

Date of registration	Nov. 05, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220909

Scientific Title	A Phase III Study of CS-8958 (Postexposure Prophylaxis) -A randomized, double-blind, placebo-controlled, confirmative study of CS-8958 for prevention of influenza-
Public Title	A Phase III Study of CS-8958 (Postexposure Prophylaxis)

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	DAIICHI SANKYO COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		600
Study Type		Interventional
Study Design	Study Design	Multi-center, randomized, 3-parallel-group, double-blind, placebo-controlled
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects judged as negative for influenza virus infection using a specified diagnostic kit Subjects who have an axillary temperature <=36.9°C when giving informed consent to the study.
	Exclusion Criteria	Subjects who are not able to live with index cases Subjects with severe renal dysfunction or under dialysis treatment Subjects who have treatment with adrenocorticoids, or immunosuppressive drugs
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Type A or type B influenza 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 : CS-8958 to be inhaled once weekly (two times) control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo to be inhaled once weekly (two times)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Proportion of clinical laboratory-confirmed influenza infection with symptoms
Secondary Outcome		Proportion of laboratory-confirmed influenza 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-090941
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Sept. 19, 2014	Detail	Changes
6	Sept. 18, 2014	Detail	Changes
5	Jan. 27, 2011	Detail	Changes
4	Nov. 30, 2010	Detail	Changes
3	Nov. 30, 2010	Detail	Changes
2	Nov. 05, 2009	Detail	Changes
1	Nov. 05, 2009	Detail

List of change history