[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581149":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":90,"collaborators":24,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":24,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Apollo Therapeutics Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: in adults with WHO Group 1 PAH.","EXPERIMENTAL","Three (3) APL-9796 dose levels are planned for evaluation using BOIN design.",[13],"Drug: APL-9796",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B (optional): in adults with WHO Group 3 PH-ILD","Cohorts will be enrolled sequentially at N=4, at a dose level determined by the Safety Review Committee (SRC) based on data from Part A.",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","APL-9796","3 Cohorts are planned in Part A.",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC).",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Sanjay Aggarwal, MD","CONTACT","781-479-2267","AP13@apollotx.com",[35,53,61,69,77,82],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hammersmith\u002FImperial Hospital","RECRUITING","London","W12 0HS","United Kingdom","UK",{"type":43,"coordinates":44},"Point",[45,46],-0.12574,51.50853,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":51,"phoneExt":24,"email":52},"Luke Howard, Professor","+44 20 3313 3171","l.howard@imperial.nhs.uk",{"facility":54,"status":37,"city":55,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":24},"Royal United Hospital Bath","Bath",{"type":43,"coordinates":57},[58,59],-2.36172,51.3751,{"lat":59,"lon":58},{"facility":62,"status":37,"city":63,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":64,"geoPoint":68,"contacts":24},"Royal Papworth Hospital","Cambridge",{"type":43,"coordinates":65},[66,67],0.11667,52.2,{"lat":67,"lon":66},{"facility":70,"status":37,"city":71,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":72,"geoPoint":76,"contacts":24},"Golden Jubilee Hospital","Clydebank",{"type":43,"coordinates":73},[74,75],-4.4057,55.90137,{"lat":75,"lon":74},{"facility":78,"status":37,"city":38,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":79,"geoPoint":81,"contacts":24},"Royal Brompton Hospital",{"type":43,"coordinates":80},[45,46],{"lat":46,"lon":45},{"facility":83,"status":37,"city":84,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":85,"geoPoint":89,"contacts":24},"Sheffield Teaching Hospitals","Sheffield",{"type":43,"coordinates":86},[87,88],-1.4659,53.38297,{"lat":88,"lon":87},{"type":91,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100581149","phase-2-a-trial-of-apl-9796-in-adults-with-pulmonary-hypertension-100581149",false,"NCT06846554","A Trial of \"APL-9796'' in Adults With Pulmonary Hypertension","A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)","ViTAL-PH","Inclusion Criteria:\n\n1. Participant must be 18 to 80 years of age inclusive\n2. Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.\n3. WHO Functional Class II or III\n4. Participant has the CardioMEMS PA Sensor implanted.\n\nExclusion Criteria:\n\n1. Hospital admission related to PH within 3 months prior to Screening.\n2. Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator\n3. Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease\n4. History of left-sided heart disease and\u002For clinically significant cardiac disease\n5. History of uncontrolled systemic hypertension\n6. eGFR ≤30 ml\u002Fmin\u002F1.73m2\n7. Life expectancy of \\\u003C 12 months, as assessed by the Investigator\n8. Diagnosed with a malignancy within 5 years of enrolment\n9. Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods","ALL","18 Years","80 Years",{"count":104,"type":105},48,"ESTIMATED","INTERVENTIONAL",[108],"PHASE2","The AP13CP02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (SC) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796.\n\nThe trial will be conducted in two parts:\n\n* Part A: Up to 36 adults with WHO Group 1 Pulmonary arterial hypertension (PAH).\n* Part B (optional): Up to 12 adults with WHO Group 3 - PH associated with ILD (PH-ILD).",[111],"Pulmonary Arterial Hypertension",[113,114,115],"Pulmonary Hypertension","WHO group 3","WHO group 1 PH","2026-05-06",{"date":118,"type":119},"2026-05-11","ACTUAL",{"date":121,"type":119},"2025-04-09",{"date":123,"type":105},"2027-09-30",{"name":5,"class":6},6]