UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Uncontrolled study of post-exposure prophylaxis for influenza by peramivir
Title of the study (Brief title)	Post-exposure prophylaxis for influenza by peramivir
Region	Japan

Condition
Condition	Patients exposed to influenza
Classification by specialty	Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of permivir in patient who were exposed by influenza to prevent the secondary onset of influenza.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Secondary infection of patients received peramivir after influenza exposure.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	A single dose of Peramivir 300mg is intravenously injected.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who contacted with other influenza patients. (2) Patients who cannot take oseltamivir orally or inhale zanamivir. (3) Patients who need prevention of influenza virus infection. (4) Patients who were explained with this study and accept to receive Permivir.
Key exclusion criteria	Patients who were judged to be inadequate for this study.
Target sample size	10

Research contact person
Name of lead principal investigator	Nobuhisa Ishiguro
Organization	Hokkaido University Hospital
Division name	Infection Control Team
Address	North-14, West-5, Kita-ku, Sapporo
TEL	011-706-5703
Email	nishigur@med.hokudai.ac.jp

Public contact
Name of contact person	Nobuhisa Ishiguro
Organization	Hokkaido University Hospital
Division name	Infection Control Team
Address	North-14, West-5, Kita-ku, Sapporo
TEL	011-706-5703
Homepage URL
Email	nishigur@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital, Infection Control Team
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 10 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 09 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016888