UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003095 |
|---|---|
| Receipt number | R000003758 |
| Scientific Title | Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction. |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2021/09/06 09:58:24 |
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Basic information
Public title
Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction.
Acronym
HLA-B*5701 screening for prevention of abacavir hypersensitivity reaction.
Scientific Title
Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction.
Scientific Title:Acronym
HLA-B*5701 screening for prevention of abacavir hypersensitivity reaction.
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Proportion of abacavir-hypersensitive patients to the HLA-B*5701-negative.
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
| Gene |
Interventions/Control_1
Abacavir is administered to HLA-B*5701-negative patients and the hypersensitivity will be judged in six weeks.
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
HIV-infected patients, irrespective of antiretroviral treatment experience, considered to initiate a regimen containing abacavir.
Key exclusion criteria
Patients received abacavir once, or with severe hepatic dysfunction.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Igarashi |
Organization
University of Fukui Hospital
Division name
Department of Pharmacy
Zip code
Address
23-3, Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan.
TEL
0776-61-3111(ext.3212)
igarashi@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Igarashi |
Organization
University of Fukui Hospital
Division name
Department of Pharmacy
Zip code
Address
23-3, Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan.
TEL
0776-61-3111(ext.3212)
Homepage URL
igarashi@u-fukui.ac.jp
Sponsor or person
Institute
Department of Pharmacy, University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
福井大学医学部附属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 26 | Day |
Last modified on
| 2021 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003758
| 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 |
