UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Double-blind Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza
Title of the study (Brief title)	Double-blind Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza
Region	Japan

Condition
Condition	Influenza
Classification by specialty	Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare efficacy and safety of Baloxavir marboxil and Peramivir for pediatric influenza virus infection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The time to alleviation of influenza symptoms The time to resolution of fever
Key secondary outcomes	The changes from baseline in infectious virus and viral RNA titers

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Baloxavir marboxil
Interventions/Control_2	Peramivir
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1)axillary temperature more than 37.5 degree 2)a positive rapid antigen test for influenza virus 3)a symptom duraiton of no more than 36 hours 4)hospitalized patient 5)body weight more than 10kg
Key exclusion criteria	1)patients who have suffered from bacterial infection or other viral infection within one week from the start of the study 2)patients who received recipes of Baloxavir marboxil, Oseltamivir, Zanavivir, Laninavir, Peramivir within 4 weeks from the start of the study
Target sample size	40

Research contact person
Name of lead principal investigator	Atsuko Hata
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name	Department of Pediatrics
Address	2-4-20 Ohgimachi Kitaku Osaka Japan
TEL	+81-6-6312-1221
Email	ahata@kitano-hp.or.jp

Public contact
Name of contact person	Kentaro Kato
Organization	The Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name	Department of Pediatrics
Address	2-4-20 Ohgimachi Kitaku Osaka Japan
TEL	+81-6-6312-1221
Homepage URL
Email	kenkato100@gmail.com

Sponsor
Institute	Kitano Hospital, Tazuke Kofukai Medical Research Institute. Department of Pediatrics
Institute
Department

Funding Source
Organization	Kitano Hospital, Tazuke Kofukai Medical Research Institute. Department of Pediatrics
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	2018 Year 11 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 11 Month 12 Day
Anticipated trial start date	2018 Year 11 Month 14 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	2018 Year 11 Month 12 Day
Last modified on	2018 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039755