HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness

ConditionsGout Initiating Urate-loweringUrate-lowering Therapy Gout Arthritis Gout and Hyperuricemia

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorHaiphong University of Medicine and Pharmacy

About this trial

Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), are rare but life-threatening complications that can occur after starting allopurinol for gout. The HLA-B58:01 allele is a strong genetic risk factor for allopurinol-associated SCARs in Asian populations. This study evaluates the feasibility and clinical value of HLA-B58:01 screening before first-time allopurinol use in Vietnamese adults with gout.

Adults (≥18 years) diagnosed with gout (ACR/EULAR 2020 criteria) and initiating urate-lowering therapy will be enrolled at Hai Phong International General Hospital (January 2025-June 2027). Participants who undergo HLA-B58:01 genotyping (PCR-based assay) will be treated according to test results: HLA-B58:01 negative participants receive allopurinol; HLA-B58:01 positive participants receive febuxostat. A comparison group consists of patients treated with febuxostat without HLA testing. Participants will be followed for 12 months with assessments at baseline, 1, 3, 6, and 12 months to monitor serum uric acid, gout flares, and safety outcomes (SCARs and other adverse events, including liver and kidney function). The study also includes an economic evaluation to estimate the cost-effectiveness of HLA-B58:01 screening for preventing SCARs and optimizing gout treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years.

Disqualifiers

Prior use of allopurinol or history of hypersensitivity reaction to allopurinol.

Trial design

Design model

Parallel

Treatments tested in this trial

HLA-B*58:01 Genotyping
Diagnostic test
Whole-blood sample is collected for HLA-B58:01 genotyping using a PCR-based assay with allele-specific primers. Results are classified as HLA-B58:01 positive or negative and are used to guide urate-lowering therapy selection (allopurinol for negative; febuxostat for positive).
Allopurinol Tablet
Drug
Oral allopurinol is initiated as urate-lowering therapy in participants who are HLA-B\*58:01 negative. Dosing and titration follow routine clinical practice with consideration of kidney function and serum urate targets. Participants are followed for 12 months with scheduled visits to assess serum urate control, gout flares, and safety outcomes including active surveillance for severe cutaneous adverse reactions (SCARs).
Febuxostat
Drug
Oral febuxostat is used as an alternative urate-lowering therapy for participants who are HLA-B\*58:01 positive to avoid allopurinol-associated SCAR risk, and for a comparison cohort treated without HLA testing. Participants are followed for 12 months with scheduled visits to evaluate serum urate response, gout flares, and safety (including SCAR surveillance and routine liver/kidney function monitoring).

Treatment groups

228 Participants

are divided into 3 treatment groups

Group A: HLA-B*58:01 Negative: AllopurinolActive comparator 2 interventions

Group B: HLA-B*58:01 Positive: FebuxostatActive comparator 2 interventions

Group C: No HLA-B*58:01 Testing: FebuxostatActive comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of Participants Achieving Target Serum Uric Acid <5.0 mg/dL (≈300 µmol/L)

Serum uric acid is measured by venous blood sampling using an automated biochemistry analyzer at baseline and follow-up visits (1, 3, 6, and 12 months). The primary endpoint is the proportion of participants who achieve the target serum uric acid level \<5.0 mg/dL (approximately \<300 µmol/L) at the 12-month visit.

Time frame

At Month 12 after initiation of urate-lowering therapy

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haiphong University of Medicine and Pharmacy

Lead sponsor

Source ClinicalTrials.gov

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