UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020696 |
|---|---|
| Receipt number | R000023698 |
| Scientific Title | Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infected elderly patients with underlying disease |
| Date of disclosure of the study information | 2016/01/23 |
| Last modified on | 2016/01/22 11:06:09 |
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Basic information
Public title
Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infected elderly patients with underlying disease
Acronym
Safety and efficacy of peramivir against influenza virus infected elderly patients with underlying disease
Scientific Title
Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infected elderly patients with underlying disease
Scientific Title:Acronym
Safety and efficacy of peramivir against influenza virus infected elderly patients with underlying disease
Region
| Japan |
Condition
Condition
Influenza virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of peramivir
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the time from administration to return to normal temperatures
Key secondary outcomes
mortality, adverse events
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
| 65 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients 65 years or older who had been hospitalized with influenza treated with peramivir during February-2012 March 2015.
Key exclusion criteria
outpatients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamatsu Kazufumi |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Department of Respiratory medicine
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL
06-6312-1221
k-takamastu@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamatsu Kazufumi |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Department of Respiratory medicine
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL
06-6312-1221
Homepage URL
k-takamastu@kitano-hp.or.jp
Sponsor or person
Institute
Department of Respiratory medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan
Institute
Department
Personal name
Funding Source
Organization
no fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2016 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is a retrospective observational study to examine the efficacy and safety of peramivir against influenza elderly patients with underlying disease
Management information
Registered date
| 2016 | Year | 01 | Month | 22 | Day |
Last modified on
| 2016 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023698
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
