UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014519 |
|---|---|
| Receipt number | R000016888 |
| Scientific Title | Uncontrolled study of post-exposure prophylaxis for influenza by peramivir |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2016/06/15 11:54:56 |
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Basic information
Public title
Uncontrolled study of post-exposure prophylaxis for influenza by peramivir
Acronym
Post-exposure prophylaxis for influenza by peramivir
Scientific Title
Uncontrolled study of post-exposure prophylaxis for influenza by peramivir
Scientific Title:Acronym
Post-exposure prophylaxis for influenza by peramivir
Region
| Japan |
Condition
Condition
Patients exposed to influenza
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of permivir in patient who were exposed by influenza to prevent the secondary onset of influenza.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Secondary infection of patients received peramivir after influenza exposure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
A single dose of Peramivir 300mg is intravenously injected.
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
(1) Patients who contacted with other influenza patients. (2) Patients who cannot take oseltamivir orally or inhale zanamivir. (3) Patients who need prevention of influenza virus infection. (4) Patients who were explained with this study and accept to receive Permivir.
Key exclusion criteria
Patients who were judged to be inadequate for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Ishiguro |
Organization
Hokkaido University Hospital
Division name
Infection Control Team
Zip code
Address
North-14, West-5, Kita-ku, Sapporo
TEL
011-706-5703
nishigur@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Ishiguro |
Organization
Hokkaido University Hospital
Division name
Infection Control Team
Zip code
Address
North-14, West-5, Kita-ku, Sapporo
TEL
011-706-5703
Homepage URL
nishigur@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Infection Control Team
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
| 2014 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
Management information
Registered date
| 2014 | Year | 07 | Month | 09 | Day |
Last modified on
| 2016 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016888
