NCT03046914

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

Status unknown NA Last updated 8 February 2017

What this trial tests

NA trial testing HLA-B*5801 test in Stevens-Johnson Syndrome in 600 participants. Status unknown.

Timeline

24 February 2016

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	600
Start date	24 February 2016
Primary completion	30 November 2017
Estimated completion	30 November 2017
Sites	1 location across South Korea

Drugs / interventions tested

• HLA-B*5801 test

Conditions studied

• Stevens-Johnson Syndrome — all drugs for Stevens-Johnson Syndrome →
• Kidney Failure, Chronic — all drugs for Kidney Failure, Chronic →

Sponsor

Seoul National University Hospital

Who can join

Eligibility, any sex, with Stevens-Johnson Syndrome or Kidney Failure, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.