UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034870 |
|---|---|
| Receipt number | 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 18:37:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kenkato100@gmail.com
Sponsor or person
Institute
Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Department of Pediatrics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039755
