An interventional study of HLA-B*5801 test in Stevens-Johnson Syndrome and Kidney Failure, Chronic, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2017-02-08.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
40 studies on the registry are indexed under Stevens-Johnson Syndrome; 9 are open to participants now.
This study's planned enrollment of 600 is above the median of 20 across 24 interventional studies indexed under Stevens-Johnson Syndrome.
Browse Stevens-Johnson Syndrome studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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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
Exclusion Criteria:
An arm in which a participant takes HLA-B\*5801 test before administration of allopurinol
Genetic: HLA-B*5801 test
Check whether a participant has HLA-B\*5801 allele or not, before administration of allopurinol
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 \[Three out of four asterisked (\*) criteria are required for making the diagnosis.\]
Time frame: Before 3 months after initiation of allopurinol
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital