[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643360":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":39,"centralContacts":40,"locations":39,"responsibleParty":46,"collaborators":39,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":39,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":39,"enrollmentInfo":58,"targetDuration":39,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":84,"whyStopped":39,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":39},{"fullName":5,"class":6},"Atavistik Bio, Inc","INDUSTRY",[8,14,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: 60 mg QD","EXPERIMENTAL","Active drug, once daily",[13],"Drug: ATV-1601",{"label":15,"type":10,"description":11,"interventionNames":16},"Part 1: 100 mg QD",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"Part 1: 60 BID","Active drug, twice daily",[13],{"label":22,"type":10,"description":23,"interventionNames":24},"Part 1: Placebo","Control Arm",[25],"Drug: Placebo",[27,34],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","ATV-1601","Administered orally, daily",[15,18,9],[33],"Active drug, capsule",{"type":28,"name":35,"description":30,"armGroupLabels":36,"otherNames":37},"Placebo",[22],[38],"Inactive, Placebo",null,[41],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":45},"Study Director","CONTACT","857-285-5400","Studydirector@atavistikbio.com",{"type":47,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","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":59,"type":60},100,"ESTIMATED","INTERVENTIONAL",[63,64],"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.",[67,68],"Hereditary Hemorrhagic Telangiectasia (HHT)","Osler Weber Rendu Disease",[70,29,71,72,73,74,75,76,77,78,79,80,81,82,83],"Arteriovenous malformations","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":87,"type":88},"2026-06-08","ACTUAL",{"date":90,"type":60},"2026-06",{"date":92,"type":60},"2030-03",{"name":5,"class":6}]