UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009709
Receipt No. R000011382
Scientific Title The role of reactivation of human herpes virus in drug-induced hypersensitivity syndrome
Date of disclosure of the study information 2013/01/07
Last modified on 2014/03/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The role of reactivation of human herpes virus in drug-induced hypersensitivity syndrome
Acronym The role of reactivation of human herpes virus in drug-induced hypersensitivity syndrome
Scientific Title The role of reactivation of human herpes virus in drug-induced hypersensitivity syndrome
Scientific Title:Acronym The role of reactivation of human herpes virus in drug-induced hypersensitivity syndrome
Region
Japan

Condition
Condition Drug-induced hypersensitivity syndrome
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the pathogenic mechanism of drug-induced hypersensitivity syndrome
Basic objectives2 Others
Basic objectives -Others To clarify the pathogenic mechanism of drug-induced hypersensitivity syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Viral DNA amount and the concentration of cytokine/ chemokine in blood and saliva
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Drug-induced hypersensitivity syndrome group
Interventions/Control_2 Healthy control group
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 drug-induced hypersensitivity syndrome
Key exclusion criteria Patients regarded as inadequate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoya Watanabe
Organization Yokohama City University Graduate School of Medicine
Division name Environmental Immuno-Dermatology
Zip code
Address Fukuura 3-9, Kanazawa, Yokohama
TEL 045-787-2675
Email nabetomo0968@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Watanabe
Organization Yokohama City University Graduate School of Medicine
Division name Environmental Immuno-Dermatology
Zip code
Address Fukuura 3-9, Kanazawa, Yokohama
TEL 045-787-2675
Homepage URL
Email nabetomo0968@yahoo.co.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nara Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 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
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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 07 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
2013 Year 01 Month 06 Day
Last modified on
2014 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011382

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.