[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557466":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":92,"collaborators":24,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":24,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":24,"enrollmentInfo":103,"targetDuration":24,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Precigen, Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 Vector Shedding","EXPERIMENTAL","Zopa administered subcutaneously at 5 × 10\\^11 particle units on Day 1, Week 2, Week 6, and Week 12. Samples for vector shedding to be collected from urine, feces, skin, and nasal tissue.",[13],"Drug: Zopapogene imadenovec (Zopa)",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2 Retreatment","Patients with prior treatment with Zopa (5 × 10\\^11 PU per injection) and require clinically indicated debulking procedure",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Zopapogene imadenovec (Zopa)","Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Amy Lankford, PhD","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Head of Clinical Operations","CONTACT","301-556-9900","clinicaltrials@precigen.com",[36,58,75],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Winship Cancer Institute, Emory University","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-84.38798,33.749,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":24,"email":54},"Mosope Oyewole, CRC","404-778-5351","mdoyewo@emory.edu",{"name":56,"role":57,"phone":24,"phoneExt":24,"email":24},"Nabil Saba, MD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":38,"city":60,"state":61,"zip":62,"country":42,"countryCode":43,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"National Institute of Health","Bethesda","Maryland","20892",{"type":45,"coordinates":64},[65,66],-77.10026,38.98067,{"lat":66,"lon":65},[69,73],{"name":70,"role":32,"phone":71,"phoneExt":24,"email":72},"Shannon Householder, RN","240-656-8771","Shannon.householder@nih.gov",{"name":74,"role":32,"phone":24,"phoneExt":24,"email":24},"Scott Norberg, DO",{"facility":76,"status":38,"city":77,"state":78,"zip":79,"country":42,"countryCode":43,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":45,"coordinates":81},[82,83],-84.51439,39.12711,{"lat":83,"lon":82},[86,90],{"name":87,"role":32,"phone":88,"phoneExt":24,"email":89},"Rebecca Reinert","513-558-1719","gibsonrk@ucmail.uc.edu",{"name":91,"role":57,"phone":24,"phoneExt":24,"email":24},"Aaron Friedman, MD",{"type":93,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100557466","phase-4-zopa-retreatment-and-vector-shedding-in-adults-with-rrp-100557466",false,"NCT06538480","Zopa Retreatment and Vector Shedding in Adults With RRP","Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis","Key Inclusion Criteria:\n\n* Age 18 years and older.\n* Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma.\n* Cohort 1: Treatment-naïve with respect to Zopa.\n* Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\\^11 PU per injection and require clinically indicated debulking procedures.\n* Presence of laryngotracheal papillomas accessible for endoscopic cleanout.\n* ECOG performance status 0 or 1.\n* Sexually active participants of reproductive potential must agree to use contraception during treatment and for 120 days for males and 6 months for females after last dose.\n* Ability to understand and sign informed consent.\n\nKey Exclusion Criteria:\n\n* Conditions or therapies that increase risk or interfere with participation per investigator judgment.\n* Systemic corticosteroids \\>10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing.\n* Other systemic RRP treatments or investigational agents within 30 days.\n* History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia.\n* Active uncontrolled HIV, hepatitis B, or hepatitis C infection.\n* Pregnant or nursing women.\n* Known allergy to any study drug component.","ALL","18 Years",{"count":104,"type":105},30,"ESTIMATED","INTERVENTIONAL",[108],"PHASE4","This open-label study evaluates safety, vector shedding, and retreatment efficacy of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). Two cohorts will be enrolled (n=30): Cohort 1 to assess the magnitude and duration of adenoviral vector shedding in urine, feces, skin, and nasal tissue; Cohort 2 to assess the complete response rate following retreatment.",[111,112,113],"Recurrent Respiratory Papillomatosis","Papillomavirus Infection","Papillomaviridae",[115,116,117,118,119,120],"Human Papilloma Virus","laryngotracheal disease","papillomatous disease","Viral Shedding","Retreatment","Zopapogene imadenovec","2025-12-11",{"date":123,"type":124},"2025-12-15","ACTUAL",{"date":126,"type":124},"2024-07-11",{"date":128,"type":105},"2028-12-02",{"name":5,"class":6},3]