Unique ID issued by UMIN | UMIN000021060 |
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Receipt number | R000024282 |
Scientific Title | Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study. |
Date of disclosure of the study information | 2016/02/16 |
Last modified on | 2019/01/30 13:40:05 |
Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.
Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.
Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.
Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.
Japan |
Pediatric patients with influenza B virus infection
Medicine in general | Pediatrics |
Others
NO
To evaluate the clinical and virological effects of NA inhibitors(peramivir, oseltamivir) on influenza B virus infection and safely in children. also to examine for the presence or absence of relapse.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Time to less than lower limit of quantification of virus titer from the start of drug treatment
*Time to return to normal body temperature (below 37.5 degrees)
*Time to resolution of flu symptoms
*Time-weighted change from baseline in the virus titer at day 3 and final observation time
*The drug sensitivity change for each NA inhibitor
*Rate of relapse
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
Central registration
2
Treatment
Medicine |
Oseltamivir
Peramivir
4 | years-old | <= |
13 | years-old | > |
Male and Female
1) Patients between 4 years and 12 years old.
2) Patients or guardian of the patients from whom obtained voluntary written informd consent.
3) Out patients with febrile symptom.
4) Patient who consulted within 48 hours after onset of fever over 37.5 degrees.
5) Patients who showed positive resut of rapid antigen test of Influenza B
1)History of hypersensitivity caused by neuraminidase inhibitors.
2)Patients with underlying disease as high risk factors that is likely to affect variation of virus.
3)Patients were deemed inappropriate for the study participants.
70
1st name | |
Middle name | |
Last name | Nobuo Hirotsu |
Hirotsu Clinic
Internal Medicine, Pediatrics
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
044-822-1933
non-hirotsu@umin.ac.jp
1st name | |
Middle name | |
Last name | Nobuo Hirotsu |
Hirotsu Clinic
Internal Medicine, Pediatrics
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
044-822-1933
non-hirotsu@umin.ac.jp
Hirotsu Clinic
Self funding
Self funding
NO
2016 | Year | 02 | Month | 16 | Day |
Unpublished
Suspended
2016 | Year | 02 | Month | 10 | Day |
2016 | Year | 02 | Month | 16 | Day |
2016 | Year | 02 | Month | 16 | Day |
2019 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024282
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