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NCT06538480 · ClinicalTrials.gov registry record · Phase 4
Zopa Retreatment and Vector Shedding in Adults With RRP
A Phase 4 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infection, sponsored by Precigen.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT06538480: Recruiting Phase 4 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infection, sponsored by Precigen.
NCT06538480 is a Phase 4 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infection that is actively recruiting participants, run by Precigen. The registered enrollment target is 30 participants, below the 34-participant average among 6 other Recurrent Respiratory Papillomatosis trials with a reported enrollment target (12% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06538480, a Phase 4 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infection, is actively recruiting participants, sponsored by Precigen.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Magnitude and duration of Zopa vector shedding measured in urine, fecal, skin, and nasal tissue
Conditions Studied
Interventions
- DRUG Zopapogene imadenovec (Zopa)
Study Locations (3)
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Maryland
- National Institute of Health - Bethesda
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2028-12-02 |
| Phase | Phase 4 |
What NCT06538480 shows while recruiting
NCT06538480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 34-participant average among 6 other Recurrent Respiratory Papillomatosis trials with a reported enrollment target (12% lower).
The record links to 3 conditions, with Recurrent Respiratory Papillomatosis appearing as the primary indexed condition, and to 1 intervention - of which Zopapogene imadenovec (Zopa) is the first listed.
NCT06538480 reports a single indexed study location in Georgia, Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT06538480 about?
NCT06538480 is a clinical study titled "Zopa Retreatment and Vector Shedding in Adults With RRP". 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, fece...
What is the current status of trial NCT06538480?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2024-07-11. Estimated completion is 2028-12-02.
What conditions does trial NCT06538480 study?
This clinical trial studies the following conditions: Recurrent Respiratory Papillomatosis, Papillomavirus Infection, Papillomaviridae.
What interventions are being tested in trial NCT06538480?
The interventions under investigation include: Zopapogene imadenovec (Zopa) (DRUG).
Who is sponsoring clinical trial NCT06538480?
This trial is sponsored by Precigen, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06538480 being conducted?
This trial has 3 study locations across Georgia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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