[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"papillomaviridae\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:papillomaviridae":28},{"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":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Recurrent Respiratory Papillomatosis","Papillomavirus Infection","Papillomaviridae",[30,31,32,33,34,35],"Human Papilloma Virus","laryngotracheal disease","papillomatous disease","Viral Shedding","Retreatment","Zopapogene imadenovec","RECRUITING","2025-12-11",{"date":39,"type":40},"2025-12-15","ACTUAL",{"date":42,"type":40},"2024-07-11",{"date":44,"type":20},"2028-12-02",{"name":46,"class":47},"Precigen, Inc","INDUSTRY",3]