A Phase 4 interventional study of HLA-B*58:01 Genotyping and Allopurinol Tablet in Gout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis and Gout and Hyperuricemia, sponsored by Haiphong University of Medicine and Pharmacy. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Haiphong University of Medicine and Pharmacy · Phase 4, Interventional, and Treatment
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.
Background and rationale: Allopurinol is a first-line urate-lowering therapy for gout but is a leading cause of severe cutaneous adverse reactions (SCARs), including SJS/TEN and DRESS. These reactions carry substantial morbidity, mortality, and healthcare costs. Genetic susceptibility-particularly carriage of HLA-B*58:01-has been consistently associated with allopurinol-induced SCARs, and pre-treatment HLA screening has reduced SCARs in several Asian settings. However, implementation evidence in Vietnam remains limited. This study is designed to generate local clinical and economic evidence to support an HLA-guided prescribing strategy.
Study objectives:
Describe the prevalence of HLA-B*58:01 among adult Vietnamese patients with gout initiating allopurinol for the first time.
Compare effectiveness and safety outcomes between an HLA-guided strategy (allopurinol for HLA-B58:01 negative; febuxostat for HLA-B58:01 positive) and a non-tested febuxostat strategy.
Evaluate the cost-effectiveness of HLA-B*58:01 screening in preventing SCARs and informing treatment selection.
Study setting and timeframe: Single-center study at Hai Phong International General Hospital, Vietnam, from January 2025 to June 2027.
Design overview:
Descriptive cross-sectional component to estimate HLA-B*58:01 positivity among tested, eligible patients.
Prospective comparative follow-up over 12 months to evaluate real-world effectiveness and safety of urate-lowering strategies.
Cost-effectiveness analysis using direct medical costs.
Participants:
Inclusion criteria include age ≥18 years, gout diagnosis according to ACR/EULAR 2020, first-time indication for allopurinol, and willingness to provide clinical data and undergo HLA testing (for tested groups). Exclusion criteria include prior allopurinol exposure or prior allopurinol hypersensitivity, severe comorbid/complex conditions likely to confound treatment (e.g., end-stage kidney disease, advanced malignancy, bone marrow transplantation, current immunosuppression), or inability to adhere to follow-up.
Interventions/Groups:
Group 1 (HLA-B*58:01 negative; allopurinol): participants tested negative and start allopurinol.
Group 2 (HLA-B*58:01 positive; febuxostat): participants tested positive and use febuxostat as an alternative.
Group 3 (No HLA test; febuxostat): participants treated directly with febuxostat without HLA testing.
Procedures and follow-up schedule:
HLA-B*58:01 genotyping is performed on whole blood using PCR with sequence-specific primers; results are classified as positive or negative.
Follow-up visits at baseline, 1, 3, 6, and 12 months.
Clinical and laboratory monitoring includes serum uric acid and safety labs (AST/ALT, creatinine/eGFR) at predefined time points; gout flare frequency and severity are recorded (including pain assessment using VAS).
SCARs are actively surveilled and clinically diagnosed; supportive laboratory findings include eosinophilia and hepatic/renal involvement when applicable.
Outcome measures:
Genetic outcome: prevalence of HLA-B*58:01 positivity among tested participants.
Effectiveness outcomes: change in serum uric acid over time; proportion achieving target uric acid control; frequency and severity of gout flares during follow-up.
Safety outcomes: incidence of SCARs (SJS, TEN, DRESS); other adverse events including liver enzyme elevation and renal function deterioration; mild hypersensitivity manifestations (e.g., pruritus, urticaria).
Economic outcomes: direct costs of HLA testing, drug therapy, laboratory monitoring, and SCAR management (hospitalization, medications, procedures, investigations). Cost-effectiveness metrics include the cost per unit of SCAR risk reduction and comparative total costs between strategies.
Sample size considerations:
A descriptive sample size is calculated to estimate HLA-B*58:01 prevalence, and a comparative sample size is calculated for effectiveness/safety comparisons between allopurinol and febuxostat strategies; the planned comparative cohort is approximately 114 participants per treatment strategy group.
Ethics:
The study is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Participants provide informed consent; confidentiality is maintained; participants may withdraw at any time without affecting standard clinical care.
47 studies on the registry are indexed under Arthritis, Gouty; 16 are open to participants now.
This study's planned enrollment of 228 is above the median of 140 across 35 interventional studies indexed under Arthritis, Gouty.
Browse Arthritis, Gouty studies →Haiphong University of Medicine and Pharmacy is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of gout according to the 2020 ACR/EULAR classification criteria.
Indicated for initiation of urate-lowering therapy (ULT) and allopurinol-naïve (no prior allopurinol exposure).
Able and willing to comply with scheduled follow-up visits (baseline, Months 1, 3, 6, and 12).
Provides written for participation.
For the genotyping arms: provides consent for blood sampling and HLA-B*58:01 genotyping.
Exclusion Criteria:
Known hypersensitivity to febuxostat (for participants who would receive febuxostat).
Current or recent severe skin reaction (suspected/confirmed SCAR) from any cause.
End-stage kidney disease requiring dialysis or kidney transplantation.
Severe hepatic impairment or active severe liver disease (e.g., /ALT >3× at baseline).
Severe uncontrolled medical conditions that, in the investigator's judgment, could interfere with treatment or follow-up (e.g., decompensated heart failure, active requiring intensive treatment).
Use of systemic therapy (e.g., high-dose , biologics, chemotherapy) at enrollment.
Pregnancy or breastfeeding.
Participation in another interventional clinical study that could affect the outcomes of this study.
Inability to provide or inability to adhere to study procedures.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants test negative for HLA-B\*58:01 and initiate allopurinol as first-line urate-lowering therapy. Follow-up for 12 months with visits at baseline, 1, 3, 6, and 12 months to assess serum urate control, gout flares, and safety (including active surveillance for SCARs and routine liver/kidney function monitoring).
Diagnostic Test: HLA-B*58:01 Genotyping · Drug: Allopurinol Tablet
Participants test positive for HLA-B\*58:01 and receive febuxostat as an alternative urate-lowering therapy to avoid allopurinol-associated SCAR risk. Follow-up for 12 months with visits at baseline, 1, 3, 6, and 12 months to evaluate serum urate response, gout flares, and safety outcomes.
Diagnostic Test: HLA-B*58:01 Genotyping · Drug: Febuxostat
Participants do not undergo HLA-B\*58:01 testing and are treated directly with febuxostat as urate-lowering therapy under routine clinical practice. Follow-up for 12 months with visits at baseline, 1, 3, 6, and 12 months to assess effectiveness (serum urate control, gout flares) and safety (including SCAR surveillance and laboratory monitoring).
Drug: Febuxostat
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).
Also known as: HLA-B*5801 test, PCR-based HLA-B*58:01 typing
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).
Also known as: Xanthine oxidase inhibitor
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).
Also known as: Xanthine oxidase inhibitor
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
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the primary publication, including demographics, baseline clinical characteristics, HLA-B*58:01 status (positive/negative), treatment assignment, longitudinal serum urate values, gout flare outcomes, adverse events (including SCARs), and cost variables. No direct identifiers will be shared; no raw genetic sequence data will be provided. Supporting Information to be Shared Study protocol, statistical analysis plan, data dictionary, and analytic code. Time Frame Beginning 6 months after publication of the primary results and ending 5 years thereafter. Access Criteria Researchers who provide a methodologically sound proposal may request access. Proposals will be reviewed by the study team and approved in accordance with institutional policies and applicable regulations. Access will be granted after signing a data use agreement. Data will be shared for the purpose of scientific research only, and recipien
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the primary results and ending 5 years thereafter.
Access criteria: De-identified individual participant data (IPD) that underlie the results reported in the primary publication, along with the study protocol (and SAP/analytic code if selected), will be available upon reasonable request. Requests may be submitted by qualified researchers with a methodologically sound proposal to the corresponding author. Proposals will be reviewed by the study team and approved in accordance with institutional policies and applicable regulations. Access will be granted after execution of a data use agreement. Data will be provided in de-identified form; no direct identifiers will be shared and recipients must not attempt re-identification.
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Studies of the drugs tested here: Allopurinol · Febuxostat
Haiphong University of Medicine and Pharmacy