[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"von-hippel-lindau-deficient-clear-cell-renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:von-hippel-lindau-deficient-clear-cell-renal-cell-carcinoma":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100605808",false,"NCT07167329","Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial","The BELIEVE-VHL Trial: A Real-world Longitudinal Study on Belzutifan's Effectiveness, Pharmacogenetics, and Pharmacoeconomics in Von Hippel-Lindau (VHL) Syndrome Using the HIF2α Inhibitor Belzutifan","BELIEVE-VHL","Inclusion Criteria:\n\n* Age ≥ 14 years.\n* Clinical or genetic confirmation of von Hippel-Lindau (VHL) syndrome.\n* Presence of measurable or progressive VHL-associated tumors, as defined by RECIST 1.1 or disease-specific imaging criteria.\n* ECOG performance status of 0-2.\n* Adequate bone marrow, hepatic, and renal function as defined by laboratory reference values.\n* Ability to swallow oral medication.\n* Provision of written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Age \\\u003C 14 years.\n* Absence of a confirmed diagnosis of von Hippel-Lindau (VHL) syndrome.\n* Presence of an active malignancy outside the VHL tumor spectrum within the past 3 years, except for adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies considered cured for \\>2 years.\n* Known hypersensitivity or allergic reaction to belzutifan or any excipient in the formulation.\n* History of severe or uncontrolled cardiovascular disease, including but not limited to unstable angina, myocardial infarction within the past 6 months, congestive heart failure requiring treatment, or uncontrolled hypertension.\n* Active infectious diseases, including HIV, hepatitis B, or hepatitis C.\n* Immunosuppressed status, whether due to underlying disease or ongoing therapy.\n* History of significant bleeding disorders, including bleeding diathesis, thrombocytopenia, or coagulopathy.\n* Radiotherapy administered within 4 weeks prior to study enrollment.\n* Major surgical procedure, including for VHL-related tumors, within 4 weeks prior to study enrollment, or immediate need for surgical intervention for tumor management.\n* Malabsorption secondary to prior gastrointestinal surgery or active gastrointestinal disease.\n* Current use of concomitant medications known to interact with belzutifan and significantly alter its bioavailability.\n* Anticipated low adherence to or planned interruption of belzutifan therapy.","ALL","14 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The BELIEVE-VHL Trial is a prospective real-life study designed to evaluate the therapeutic effects, benefits, and adverse effects of belzutifan, as well as the timing of treatment response and disease progression in patients with von Hippel-Lindau (VHL) syndrome.",[26,27,28,29,30,31,32,33],"Von Hippel Lindau","Von Hippel Lindau Disease","Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma","Hemangioblastoma (HB) of the Central Nervous System (CNS)","PNET","Retinal Angiomatous Proliferation","Pheochromocytoma\u002FParaganglioma","Endolymphatic Sac Tumor",[35,36,37,38,39],"Belzutifan","von Hippel-Lindau","Renal Cell Clear Carcinoma","Hemangioblastoma of Central Nervous System","Pharmacogenetics","RECRUITING","2025-09-09",{"date":43,"type":44},"2025-09-11","ACTUAL",{"date":46,"type":44},"2024-01-01",{"date":48,"type":20},"2030-01-01",{"name":50,"class":51},"José Claudio Casali da Rocha","OTHER",1,{"id":54,"slug":4,"hasResults":10,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":10,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":52},"100558609","NCT06553339","A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors","A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy","Inclusion Criteria:\n\n1. Male or female from 18 to 80 year-old\n2. Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors\n3. Has an Eastern Cooperative Oncology Group performance status of 0-1\n4. Has a life expectancy of ≥ 12 weeks\n5. Should use adequate contraceptive measures throughout the study\n6. Females subject must not be pregnant at screening\n7. Has the ability to understand and willingness to sign a written informed consent before the performance of the study.\n\nExclusion Criteria:\n\n1. Recieved or being received treatment as follows:\n\n   1. Hypoxia-induced factor inhibitors\n   2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.\n   3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment\n   4. Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment\n   5. Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.\n   6. Major surgery within 4 weeks prior to the first dose of study treatment.\n2. Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy\n4. Has another malignancy or a history of another non-VHL syndrome associated malignancy\n5. Has inadequate bone marrow reserve or organ dysfunction\n6. Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment\n7. Has severe infections within 4 weeks prior to the first dose of study treatment\n8. Has digestive system diseases may influencing ADME of study drug\n9. Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin\n10. Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision","18 Years","80 Years",{"count":62,"type":20},60,[64],"PHASE1","The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD\u002FMAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in patients with VHL Syndrome Associated Tumors.",[28],[68,69,70,71,72],"Von Hippel Lindau Syndrome","VHL Syndrome","RCC","pNET","CNS hemangioblastoma","2024-08-12",{"date":75,"type":44},"2024-08-14",{"date":77,"type":44},"2024-07-19",{"date":79,"type":20},"2028-07-31",{"name":81,"class":82},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",""]