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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038553
Receipt No. 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 2020/02/26

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Basic information
Public title Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Acronym Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Scientific Title Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Scientific Title:Acronym Special Drug Use Surveillance in Tamiflu-Resistant Influenza Viruses
Region
Japan

Condition
Condition Influenza type A or B virus infection
Classification by specialty
Medicine in general Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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.
Key secondary outcomes (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).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria No criteria
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Nomura
Organization Chugai Pharmaceutical Co. Ltd.
Division name Drug safety division
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0769
Email nomuramkt@chugai-pharm.co.jp

Public contact
Name of contact person
1st name Ayaka
Middle name
Last name Shimizu
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real World Data Science Dept.
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0905
Homepage URL
Email shimizuayk@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization None
Address None
Tel None
Email 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
2019 Year 11 Month 12 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 Open public recruiting
Date of protocol fixation
2019 Year 06 Month 07 Day
Date of IRB
2019 Year 06 Month 07 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 11 Month 12 Day
Last modified on
2020 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043933

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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