[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osler-weber-rendu-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osler-weber-rendu-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":4},"100643360","phase-1-harmony-hht-atv-1601-in-participants-with-hereditary-hemorrhagic-telangiectasia-hht-100643360",false,"NCT07601425","Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)","A Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study of ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)","Inclusion Criteria:\n\n* Ability to provide informed consent prior to any study-specific procedures\n* Confirmed diagnosis of hereditary hemorrhagic telangiectasia (HHT) based on Curaçao criteria\n* Moderate to severe HHT with an ESS ≥ 4\n* Anemia at Screening and\u002For requirement for at least 1 red-cell unit (RUE) in the previous 6 months\n* Adequate hematologic, renal, and hepatic function per protocol-defined laboratory criteria\n* Use highly effective contraception during the study and for a protocol-defined period after last dose\n\nExclusion Criteria:\n\n* Clinically significant abnormalities of glucose metabolism including diagnosed Type 1 or uncontrolled Type 2 diabetes\n* Chronic cardiac disease, or cardiac rhythm abnormalities\n* History of significant cardiovascular, hepatic, renal, or hematologic disease not related to HHT that may confound study results\n* Use of prohibited concomitant medications within a protocol-defined washout period prior to first dose (including strong CYP modulators and certain herbal supplements)\n* Recent (within 6 weeks) major surgery or local ablative procedures, or procedures on nasal telangiectasias\n* Prior AKT inhibitor\n* Pregnant or breastfeeding women\n\nAdditional Criteria for Open-Label Extension:\n\n* Participants must complete the double-blind treatment period (Part 1)",true,"ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomized, double-blind, placebo-controlled study evaluating 3 dosing regimens of ATV-1601. Patients completing Part 1 may participate in the Part 2 open-label extension to receive ATV-1601.",[28,29],"Hereditary Hemorrhagic Telangiectasia (HHT)","Osler Weber Rendu Disease",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Arteriovenous malformations","ATV-1601","HarmonyHHT","Harmony-HHT","HarmonyHHTStudy","Vascular Diseases","Bleeding disorders","Hematologic disorders","Disorders","Telangiectasias","Hereditary hemorrhagic","Hemorrhagic disorders","Cardiovascular diseases","Vascular malformations","HHT","NOT_YET_RECRUITING","2026-06-04",{"date":49,"type":50},"2026-06-08","ACTUAL",{"date":52,"type":21},"2026-06",{"date":54,"type":21},"2030-03",{"name":56,"class":57},"Atavistik Bio, Inc","INDUSTRY"]