Back to resultsHLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction
Primary Purpose
Stevens-Johnson Syndrome, Kidney Failure, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HLA-B*5801 test
Sponsored by
About this trial
This is an interventional prevention trial for Stevens-Johnson Syndrome
Eligibility Criteria
Inclusion Criteria:
- a subject who needs an allopurinol treatment based on the physician's assessement
a subject with chronic kidney disease (CKD)
CKD is diagnosed on at least 2 occasions for a period of at least 3 months, irrespective of the underlying cause and on the basis
- an estimated or measured glomerular filtration rate <60 mL/min/1.73 m2 and/or
- evidence of kidney damage (albuminuria, proteinuria, haematuria after exclusion of urological causes, or structural abnormalities on kidney imaging tests)
Exclusion Criteria:
- a subject who refuses to participate in this study
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLA-B*5801 screen test
Arm Description
An arm in which a participant takes HLA-B*5801 test before administration of allopurinol
Outcomes
Primary Outcome Measures
An occurrence of allopurinol-induced severe cutaneous adverse reaction
# Clinical presentations
Stevens-Johnson syndrome (SJS), SJS/Toxic epidermal necrolysis (TEN) overlap and TEN were diagnosed according to the range of detached surface area (< 10 %, 10-30 %, and > 30 %, respectively).
Drug rash with eosinophilia and systemic symptoms (DRESS) was diagnosed with the following criteria; Hospitalization, Reaction suspected to be drug-related Acute rash, Fever >38°C*, Enlarged lymph nodes at a minimum of 2 sites*, Involvement of at least 1 internal organ*, Blood count abnormalities*, Lymphocytes above or below normal limits, Eosinophils above the laboratory limits, Platelets below the laboratory limits [Three out of four asterisked (*) criteria are required for making the diagnosis.]
Secondary Outcome Measures
Full Information
NCT ID
NCT03046914
First Posted
February 6, 2017
Last Updated
February 7, 2017
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03046914
Brief Title
HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction
Official Title
A Prospective Study to Prove the Usefulness of HLA-B*5801 Screening Test for the Prevention of Allopurinol-induced Severe Cutaneous Adverse Reaction in Patient With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
November 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition. Previous reports have reported that HLA-B*5801 is an important genetic risk factor significantly associated with the development of allopurinol-induced SCAR. However, there has been no prospective study to prove the clinical efficacy of a HLA-B*5801 screening before administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this prospective study is to test our hypothesis that a pre-screening of HLA-B*5801 will significantly reduce the risk of allopurinol-induced SCAR development compared to the historical control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stevens-Johnson Syndrome, Kidney Failure, Chronic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cases and historical controls
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLA-B*5801 screen test
Arm Type
Experimental
Arm Description
An arm in which a participant takes HLA-B*5801 test before administration of allopurinol
Intervention Type
Genetic
Intervention Name(s)
HLA-B*5801 test
Intervention Description
Check whether a participant has HLA-B*5801 allele or not, before administration of allopurinol
Primary Outcome Measure Information:
Title
An occurrence of allopurinol-induced severe cutaneous adverse reaction
Description
# Clinical presentations
Stevens-Johnson syndrome (SJS), SJS/Toxic epidermal necrolysis (TEN) overlap and TEN were diagnosed according to the range of detached surface area (< 10 %, 10-30 %, and > 30 %, respectively).
Drug rash with eosinophilia and systemic symptoms (DRESS) was diagnosed with the following criteria; Hospitalization, Reaction suspected to be drug-related Acute rash, Fever >38°C*, Enlarged lymph nodes at a minimum of 2 sites*, Involvement of at least 1 internal organ*, Blood count abnormalities*, Lymphocytes above or below normal limits, Eosinophils above the laboratory limits, Platelets below the laboratory limits [Three out of four asterisked (*) criteria are required for making the diagnosis.]
Time Frame
Before 3 months after initiation of allopurinol
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a subject who needs an allopurinol treatment based on the physician's assessement
a subject with chronic kidney disease (CKD)
CKD is diagnosed on at least 2 occasions for a period of at least 3 months, irrespective of the underlying cause and on the basis
an estimated or measured glomerular filtration rate <60 mL/min/1.73 m2 and/or
evidence of kidney damage (albuminuria, proteinuria, haematuria after exclusion of urological causes, or structural abnormalities on kidney imaging tests)
Exclusion Criteria:
a subject who refuses to participate in this study
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heung-Woo Park, PhD
Phone
+82-2-2072-0699
Email
guinea71@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jung-In Park
Phone
+82-2-2072-4849
Email
snuhpji@naver.com
12. IPD Sharing Statement
Learn more about this trial
HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction
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