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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034870
Receipt No. R000039755
Scientific Title Double-blind Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza
Date of disclosure of the study information 2018/11/14
Last modified on 2018/12/03

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Basic information
Public title Double-blind Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza
Acronym Double-blind Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza
Scientific Title Double-blind Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza
Scientific Title:Acronym 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
1st name
Middle name
Last name Atsuko Hata
Organization Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name Department of Pediatrics
Zip code
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
1st name
Middle name
Last name Kentaro Kato
Organization The Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name Department of Pediatrics
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 11 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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