[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621361":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":46,"locations":45,"responsibleParty":52,"collaborators":45,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":45,"maxAge":45,"enrollmentInfo":64,"targetDuration":45,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":86,"whyStopped":45,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":45},{"fullName":5,"class":6},"Haiphong University of Medicine and Pharmacy","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"HLA-B*58:01 Negative: Allopurinol","ACTIVE_COMPARATOR","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\u002Fkidney function monitoring).",[13,14],"Diagnostic Test: HLA-B*58:01 Genotyping","Drug: Allopurinol Tablet",{"label":16,"type":10,"description":17,"interventionNames":18},"HLA-B*58:01 Positive: Febuxostat","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.",[13,19],"Drug: Febuxostat",{"label":21,"type":10,"description":22,"interventionNames":23},"No HLA-B*58:01 Testing: 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).",[19],[25,33,40],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIAGNOSTIC_TEST","HLA-B*58:01 Genotyping","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).",[9,16],[31,32],"HLA-B*5801 test","PCR-based HLA-B*58:01 typing",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Allopurinol Tablet","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).",[9],[39],"Xanthine oxidase inhibitor",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Febuxostat","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\u002Fkidney function monitoring).",[16,21],[39],null,[47],{"name":48,"role":49,"phone":50,"phoneExt":45,"email":51},"Ngoc Son Ba Nguyen","CONTACT","+84916088678","son.nguyenba2012@gmail.com",{"type":53,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100621361","phase-4-hla-b5801-guided-therapy-for-gout-effectiveness-safety-and-cost-effectiveness-100621361",false,"NCT07369622","HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness","A Prospective Interventional Study Comparing Genotype-Guided Therapy Versus Usual Care to Prevent Severe Cutaneous Adverse Reactions Associated With Allopurinol and Carbamazepine in Vietnam","HLA-SCREEN","Inclusion Criteria:\n\n* Age ≥ 18 years.\n\nDiagnosis of gout according to the 2020 ACR\u002FEULAR classification criteria.\n\nIndicated for initiation of urate-lowering therapy (ULT) and allopurinol-naïve (no prior allopurinol exposure).\n\nAble and willing to comply with scheduled follow-up visits (baseline, Months 1, 3, 6, and 12).\n\nProvides written informed consent for participation.\n\nFor the genotyping arms: provides consent for blood sampling and HLA-B\\*58:01 genotyping.\n\nExclusion Criteria:\n\n* Prior use of allopurinol or history of hypersensitivity reaction to allopurinol.\n\nKnown hypersensitivity to febuxostat (for participants who would receive febuxostat).\n\nCurrent or recent severe skin reaction (suspected\u002Fconfirmed SCAR) from any cause.\n\nEnd-stage kidney disease requiring dialysis or kidney transplantation.\n\nSevere hepatic impairment or active severe liver disease (e.g., AST\u002FALT \\>3× ULN at baseline).\n\nSevere uncontrolled medical conditions that, in the investigator's judgment, could interfere with treatment or follow-up (e.g., decompensated heart failure, active malignancy requiring intensive treatment).\n\nUse of systemic immunosuppressive therapy (e.g., high-dose corticosteroids, biologics, chemotherapy) at enrollment.\n\nPregnancy or breastfeeding.\n\nParticipation in another interventional clinical study that could affect the outcomes of this study.\n\nInability to provide informed consent or inability to adhere to study procedures.",true,"ALL",{"count":65,"type":66},228,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis (SJS\u002FTEN) 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.\n\nAdults (≥18 years) diagnosed with gout (ACR\u002FEULAR 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.",[72,73,74],"Gout Initiating Urate-loweringUrate-lowering Therapy","Gout Arthritis","Gout and Hyperuricemia",[76,77,78,79,80,81,82,83,84,85],"HLA-B*58:01","HLA genotyping","Pharmacogenomics","Allopurinol","febuxostat","Pharmacogenetic screening","Severe cutaneous adverse reactions (SCARs)","Stevens-Johnson syndrome (SJS)","Toxic epidermal necrolysis (TEN)","Cost-effectiveness analysis","NOT_YET_RECRUITING","2026-01-18",{"date":89,"type":90},"2026-01-27","ACTUAL",{"date":92,"type":66},"2026-01-20",{"date":94,"type":66},"2028-12-30",{"name":5,"class":6}]