UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004835 |
|---|---|
| Receipt number | R000005755 |
| Scientific Title | Study on immune mechanisms of thrombocytopenia in secondary dengue virus infection |
| Date of disclosure of the study information | 2011/01/07 |
| Last modified on | 2011/01/07 11:07:43 |
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Basic information
Public title
Study on immune mechanisms of thrombocytopenia in secondary dengue virus infection
Acronym
Study on mechanisms on thrombocytopenia in dengue
Scientific Title
Study on immune mechanisms of thrombocytopenia in secondary dengue virus infection
Scientific Title:Acronym
Study on mechanisms on thrombocytopenia in dengue
Region
| Asia(except Japan) |
Condition
Condition
Dengue virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the mechanisms of thrombocytopenia in secondary dengue infections
Basic objectives2
Others
Basic objectives -Others
Elucidation of mechanisms
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Platelet apoptosis and platelet phagocytosis
Key secondary outcomes
Platelet count
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) acute dengue suspected cases, 2) equal or more than 10 years old,
Key exclusion criteria
1) patients with dengue hemorrhagic fever grade 4, 2) patients who require platelet transfusion with bleeding manifestation or shock, 3) younger than 10 years old
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Oishi |
Organization
Osaka University
Division name
Research Institute for Microbial Diseases
Zip code
Address
3-1 Yamadaoka, Suita city, Osaka Prefecture
TEL
06-6879-4253
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Oishi |
Organization
Osaka University
Division name
Research Institute for Microbial Diseases
Zip code
Address
3-1 Yamadaoka, Suita city, Osaka Prefecture
TEL
06-6879-4253
Homepage URL
oishik@biken.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science and Culture
The Osaka Foundation for Promotion of Clinical Immunology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
San Lazaro Hospital, St Lukes Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
RERB 2009-04
Org. issuing International ID_1
San Lzaro Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 07 | 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
The levels of platelet apoptosis from patients were significantly increased during the acute and early convalescent phase of infection compared with those of healthy controls. A significant inverse correlation was found between the levels of platelet apoptosis and the peripheral platelet counts or the levels of platelet phagocytosis among these patients during the acute phase of infection. Furthermore, a significant direct correlation between the levels of platelet phagocytosis and platelet apoptosis was also found in the acute phase of these patients. Our present data suggest a mechanism of thrombocytopenia through apoptotic platelet clearance by macrophages during the acute phase of secondary dengue virus infection.
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2011 | Year | 01 | Month | 06 | Day |
Last modified on
| 2011 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005755
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
