UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038553 |
|---|---|
| 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 | 2024/05/13 15:43:51 |
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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
Safety science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
nomuramkt@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ryousuke |
| Middle name | |
| Last name | Harada |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
haradarus@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
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
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
67
Results
The incidence of adverse events in 67 cases subject to safety analysis was 1.49% (1/67 cases), with the event being visual impairment.
No influenza viruses that were thought to have undergone resistance mutation after administration of Tamiflu were observed in this study.
The basic statistical values of the time until improvement in body temperature in 37 cases of body temperature improvement mean [standard deviation] were 39.59 [22.19] hours.
Results date posted
| 2024 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with type A or B influenza virus infection who are able to revisit between the 4th and 6th day after Tamiflu administration.
Participant flow
The study was conducted in a continuous survey manner targeting cases where influenza virus infection was definitively diagnosed by diagnostic kits, etc., and verbal consent for cooperation in the survey was obtained.
Adverse events
Adverse events were not aggregated. The incidence of adverse effects in 67 cases subject to safety analysis was 1.49% (1/67 cases), with the event being visual impairment. No serious adverse effects were observed.
Outcome measures
Presence or absence of Tamiflu-resistant virus expression
Efficacy (basic statistical measures of time until improvement in body temperature)
Virological effect
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043933
