[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gout-and-hyperuricemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gout-and-hyperuricemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100567893","phase-4-save-care-sodium-glucose-cotransporter-2-inhibitors-sglt2i-as-novel-gout-care-trial-100567893",false,"NCT06674109","SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial","SAVE-Care (SGLT2i As Novel Gout Care) Trial","SAVE-Care","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Fulfilling American College of Rheumatology \\[ACR\\]\u002FEuropean Alliance of Associations for Rheumatology \\[EULAR\\] gout criteria\n3. 1+ gout flares in last 12 months\n4. Serum urate level ≥ 6mg\u002Fdl\n5. Males and females; Age 18-80\n6. Willingness to adhere to the study intervention procedures.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Estimated Glomerular Filtration Rate \\[eGFR\\] \\\u003C20ml\u002Fmin\n2. Colchicine or nonsteroidal anti-inflammatory drug \\[NSAID\\] prophylaxis\n3. active cardiovascular disease \\[CVD\\], type-1 diabetes\n4. pregnant and lactating women\n5. Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. \\[History of ketoacidosis, end-stage or decompensated liver disease, active cancer\\]\n6. Use of anti-obesity drugs\n7. Basal-bolus or multiple daily injection insulin regimens, or loop diuretics","ALL","18 Years","80 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors \\[SGLT2i\\] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate \\[SU\\] levels of gout patients, as well as levels of highly-sensitivity C-reactive protein \\[hsCRP\\] and interleukin 6 \\[IL-6\\], and estimate gout flares over 3 months, in order to develop a full-scale RCT of clinical endpoints to directly inform gout care guidelines.",[28],"Gout and Hyperuricemia","RECRUITING","2026-06-01",{"date":32,"type":33},"2026-06-04","ACTUAL",{"date":35,"type":33},"2026-05-28",{"date":37,"type":22},"2028-02-28",{"name":39,"class":40},"Massachusetts General Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100631282","phase-2-clinical-trial-of-br2251-tablets-for-patients-with-primary-gout-and-hyperuricemia-100631282","NCT07498647","Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia","A Multicenter, Randomized, Double-blind, Non-benzylisoxazole Propionic Acid (BIPA) Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of BR2251 Tablets in Patients With Primary Gout and Hyperuricemia","BR2251-201","Inclusion Criteria:\n\n* Only those subjects who meet all the following inclusion criteria are eligible to participate in this study:\n* Voluntary participation in this trial and signing of the informed consent form, and those who can complete the trial according to the protocol;\n* Age between 18 and 75 years old (inclusive of the boundary value, based on the date of signing the informed consent form), regardless of gender;\n* Body Mass Index (BMI) ≥ 18 kg\u002Fm2 and ≤ 35 kg\u002Fm2;\n* Meeting the 2015 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) gout classification criteria, and serum uric acid (sUA) ≥ 420 μmol\u002FL during the screening period;\n* Women of reproductive age with negative pregnancy test during the screening period and before the first administration of the investigational drug (D1 \\[allowing a time window of -7 days\\]), and both female and male subjects of reproductive age must agree to voluntarily take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration of the drug\n\nExclusion Criteria:\n\n* Those who are known or suspected to be allergic to the test drug or its components, or who have previously been intolerant to febuxostat or have contraindications.\n* Subjects with secondary gout accompanied by hyperuricemia caused by other diseases or medications.\n* Those who have had acute gout attacks within the previous 2 weeks.\n* Those who have been diagnosed with uric acid nephropathy in the past or have imaging or clinical manifestations of urinary system stones (such as hematuria, back pain) within the previous 2 weeks.\n* Those with other joint lesions that the investigator considers may confuse gouty arthritis, such as rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, systemic lupus erythematosus, or joint lesions caused by chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive nephropathy, etc.\n* Those with any disease or surgical history that the investigator judges may affect the PK characteristics of the drug, such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease, digestive organ resection, kidney resection, etc.\n* Those who have used any organic anion transporter 1 and 3 (OAT1\\&3) substrate drugs within the previous 2 weeks.\n* Those who have used any other uric acid-lowering drugs within the previous 2 weeks and have other concomitant medications that affect uric acid levels (including but not limited to losartan, calcium channel blockers, fenofibrate, atorvastatin calcium, alpha-glucosidase inhibitor, insulin sensitizers, DPP4 inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, metformin) using a stable dose.\n* Those who have used aspirin within the previous 2 weeks.\n* Those who have used any diuretic within the previous 2 weeks.\n* Those with diseases that require long-term use of drugs metabolized by xanthine oxidase, including but not limited to azathioprine, mercaptopurine, etc.\n* Any abnormal laboratory test results at screening: a. Abnormal liver function, defined as AST or ALT values \\> 2× the upper limit of normal (ULN), or TBIL \\> 1.5× ULN; b. WBC \\\u003C 3.0×109\u002FL, PLT \\\u003C 75×109\u002FL, or HB \\\u003C 90 g\u002FL; c. Scr \\> 1.5× ULN, or estimated eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 using the CKD-EPI formula; d. CK \\> 1.5× ULN.\n* Viral test results at screening: a. Those with positive hepatitis B surface antigen (HBsAg) and HBV-DNA \\> 1000 IU\u002FmL; b. Those with positive HCV antibody and positive HCV-RNA; d. Those with positive HIV serum reaction; e. Those with positive syphilis antibody and requiring treatment after consultation with the infectious disease department.\n* Other serious diseases that may limit the participation of the subjects in this trial, such as: uncontrolled diabetes (glycated hemoglobin \\> 8.4% as assessed by the investigator); severe heart failure (NYHA class II or above); acute coronary syndrome, acute cerebrovascular accident within the past 6 months; coronary revascularization such as stent implantation, coronary artery bypass surgery, and other heart and large vessel-related surgeries within the past 6 months; severe arrhythmia within the past 6 months including frequent premature ventricular contractions, ventricular tachycardia, atrial fibrillation\u002Fatrial flutter, severe bradycardia; uncontrolled hypertension (greater than 160\u002F100 mmHg); severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm) etc.\n* Electrocardiogram at screening showing prolonged QTcF interval (Fridericia formula) (males \\> 450 ms, females \\> 470 ms).\n* Those who have had or currently have malignant tumors within the past 5 years (excluding skin squamous cell carcinoma, basal cell carcinoma, and cervical carcinoma in situ that have been successfully treated and without recurrence evidence).\n* Had any active infection at the time of screening, or had a severe infection within 4 weeks before randomization (requiring intravenous antimicrobial treatment or hospitalization), or had any infection that required oral antibiotic treatment within 2 weeks before randomization.\n* Have undergone organ\u002Ftissue transplantation or stem cell transplantation.\n* Within 12 weeks before randomization or within the planned period of any major surgical operation.\n* Judged by the investigator, had a history of prescription drug abuse or use of prohibited drugs within 6 months before randomization.\n* Judged by the investigator, had a daily alcohol consumption of more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer or 45 mL of alcohol with 40% content of spirits or 150 mL of wine) within 1 month before randomization.\n* Pregnant or lactating women.\n* Have participated in other drug clinical studies, and the time since the last medication is less than 30 days before screening or 5 half-lives of the original test drug (whichever is longer), or plan to participate in another drug clinical trial during the study period.\n* Those considered by the investigator to have other symptoms or conditions that are not suitable for participating in this study.","75 Years",{"count":52,"type":22},160,[54],"PHASE2","This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia.\n\nThis study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (12 weeks), and a follow-up period (2 weeks). The screened subjects were stratified based on whether their serum uric acid (sUA) was less than 480 μmol\u002FL or greater than or equal to 480 μmol\u002FL. They were randomly assigned to 4 treatment groups in a 1:1:1:1 ratio: the test drug group 1 (low-dose group), the test drug group 2 (medium-dose group), the test drug group 3 (high-dose group), and the control group (non-befloxacin tablets 40 mg), with 40 subjects in each group. Each group will use titration dosing.",[28],"NOT_YET_RECRUITING","2026-03-23",{"date":60,"type":33},"2026-03-27",{"date":62,"type":22},"2026-04-01",{"date":64,"type":22},"2026-11-30",{"name":66,"class":67},"BioRay Pharmaceutical Co., Ltd.","INDUSTRY",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100621361","phase-4-hla-b5801-guided-therapy-for-gout-effectiveness-safety-and-cost-effectiveness-100621361","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,{"count":78,"type":22},228,[25],"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.",[82,83,28],"Gout Initiating Urate-loweringUrate-lowering Therapy","Gout Arthritis",[85,86,87,88,89,90,91,92,93,94],"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","2026-01-18",{"date":97,"type":33},"2026-01-27",{"date":99,"type":22},"2026-01-20",{"date":101,"type":22},"2028-12-30",{"name":103,"class":40},"Haiphong University of Medicine and Pharmacy"]