[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Atavistik Bio, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":4},"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":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28],"Hereditary Hemorrhagic Telangiectasia (HHT)","Osler Weber Rendu Disease",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"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":48,"type":49},"2026-06-08","ACTUAL",{"date":51,"type":20},"2026-06",{"date":53,"type":20},"2030-03",{"name":55,"class":56},"Atavistik Bio, Inc","INDUSTRY",""]