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

NCT03046914 | Unknown

• 1 other identifier: SNUIMA002
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Stevens-Johnson Syndrome; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 \[Three out of four asterisked (\*) criteria are required for making the diagnosis.\]

  Before 3 months after initiation of allopurinol

Study Arms (1)

HLA-B*5801 screen test

EXPERIMENTAL

An arm in which a participant takes HLA-B\*5801 test before administration of allopurinol

Genetic: HLA-B*5801 test

Interventions

HLA-B*5801 test GENETIC

Check whether a participant has HLA-B\*5801 allele or not, before administration of allopurinol

HLA-B*5801 screen test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• a subject who refuses to participate in this study

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective cases and historical controls

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 8, 2017
• Study Start: February 24, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

KR (1)