NCT03046914

HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Stevens-Johnson Syndrome
• Kidney Failure, Chronic

Interventions

Type	Name	Description
GENETIC	HLA-B*5801 test	Check whether a participant has HLA-B\*5801 allele or not, before administration of allopurinol

Timeline

• Start date: 2016-02-24
• Primary completion: 2017-11-30
• Completion: 2017-11-30
• First posted: 2017-02-08
• Last updated: 2017-02-08

Locations

1 site across 1 country: South Korea