UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016101 |
|---|---|
| Receipt number | R000018699 |
| Scientific Title | Investigation on the efficacy and safety of favipiravir in patients who are infected or strongly suspected of being infected with Ebola virus |
| Date of disclosure of the study information | 2015/01/02 |
| Last modified on | 2017/11/15 14:15:37 |
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Basic information
Public title
Investigation on the efficacy and safety of favipiravir in patients who are infected or strongly suspected of being infected with Ebola virus
Acronym
Therapeutic effect of favipiravir on Ebola virus disease
Scientific Title
Investigation on the efficacy and safety of favipiravir in patients who are infected or strongly suspected of being infected with Ebola virus
Scientific Title:Acronym
Therapeutic effect of favipiravir on Ebola virus disease
Region
| Japan |
Condition
Condition
Ebola virus disease
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of favipiravir in patients who are infected or strongly suspected of being infected with Ebola virus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient survival at the end of study or at discontinuation
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Favipiravir is given for 14 days after study initiation.
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
Patient who met all of the following criteria is enrolled in the study.
1. Among those who met either of the following criteria I or II, the Case Management Committee evaluates the appropriateness of the subject for this study.
I. Patient who was definitively diagnosed with Ebola virus disease based on the positive PCR test.
II. Patient who developed symptoms that are consistent with Ebola virus disease within a few days prior to the onset, and who met one of the following 3 conditions.
A. Patient who previously touched the body fluids from an Ebola virus-infected patient or a suspected patient with Ebola virus disease.
B. Patient who previously touched or possibly touched any Ebola virus-infected animals, their bodies, or their flesh meat.
C. Patient with a travel history to the area where Ebola virus disease is present within 21 days prior to the onset of illness.
2. Principally, male and female aged 20 years or older. However, even minors are allowed to participate in the study only when his/her doctor understands the significance of the treatment provided in this study.
3. Patient aged 20 years or older who submitted informed consent. Proxy consent is acceptable in case the patient is incompetent to consent to the contract. For those younger than 20 years, written consent of both the patient and his/her parent (or the replacement) is required for junior-high and high school students. For primary school child or younger, written consent of his/her parent (or the replacement) is required.
Key exclusion criteria
Patient who was considered as inadequate for this study by the Case Management Committee.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kato |
Organization
National Center for Global Health and Medicine
Division name
Division of Preparedness and Emerging Infections, Disease Control and Prevention Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
ykato@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kato |
Organization
National Center for Global Health and Medicine
Division name
Division of Preparedness and Emerging Infections, Disease Control and Prevention Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
Homepage URL
ykato@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 01 | Month | 02 | 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
| 2014 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 19 | 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
| 2015 | Year | 01 | Month | 02 | Day |
Last modified on
| 2017 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018699
