Unique ID issued by UMIN | UMIN000038553 |
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Receipt number | R000043933 |
Scientific Title | Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses |
Date of disclosure of the study information | 2019/11/12 |
Last modified on | 2022/12/28 06:48:00 |
Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Japan |
Influenza type A or B virus infection
Medicine in general | Pediatrics |
Others
NO
The study is conducted to evaluate the emergence of Tamiflu-resistant influenza virus as well as efficacy and safety in patients with influenza virus infections treated with Tamiflu (Capsule 75 or Dry Syrup 3%) (below, Tamiflu).
Safety,Efficacy
Sensitivity of influenza viruses
A neuraminidase activity assay is performed to quantitatively assess sensitivity to oseltamivir (as expressed by IC50) using the isolated viral neuraminidase of isolated and identified influenza viruses. If sensitivity (as expressed by IC50) is reduced (increased IC50), the neuraminidase and hemagglutinin genes of the isolated virus are analyzed.
- Sensitivity by influenza virus type.
- Rate of influenza virus resistance and its 95% confidence interval.
- Variation in sensitivity will be considered.
- Variation in neuraminidase and hemagglutinin amino acids will be considered.
(1)Efficacy
(1-1)Duration of pyrexia:to
For patients with body temperature over 37.8 immediately before taking Tamiflu, the period from the time when Tamiflu treatment started to the time when body temperature
Decreased to under 36.9 (in chidren, under 37.4).
However, when comparing to data from the development phase, patients with body temperature over 38.0 immediately before taking Tamiflu will be considered.
(1-2)Duration of symptoms:
For patients in whom influenza symptoms were classified as Moderate or Severe immediately before taking Tamiflu, the period from the time when Tamiflu treatment started to the time when all influenza symptoms became Absent or Mild.
(2)Safety
Incidences of adverse events and adverse drug reactions (by SOC and symptom).
Observational
Not applicable |
Not applicable |
Male and Female
Patients with influenza A or B virus infection who are able to visit the hospital again between 4 and 6 days after starting Tamiflu treatment
No criteria
200
1st name | Makoto |
Middle name | |
Last name | Nomura |
Chugai Pharmaceutical Co. Ltd.
Safety science Dept.
1038324
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
03-3281-6611
nomuramkt@chugai-pharm.co.jp
1st name | Ryousuke |
Middle name | |
Last name | Harada |
Chugai Pharmaceutical Co. Ltd.
Safety Science Dept.
1038324
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
03-3281-6611
haradarus@chugai-pharm.co.jp
Chugai Pharmaceutical Co. Ltd.
Chugai Pharmaceutical Co. Ltd.
Profit organization
None
None
None
None
NO
2019 | Year | 11 | Month | 12 | Day |
Unpublished
Open public recruiting
2019 | Year | 06 | Month | 07 | Day |
2019 | Year | 06 | Month | 07 | Day |
2019 | Year | 10 | Month | 01 | Day |
2022 | Year | 12 | Month | 31 | Day |
None
2019 | Year | 11 | Month | 12 | Day |
2022 | Year | 12 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043933
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