Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06538480 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Zopa Retreatment and Vector Shedding in Adults With RRP

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Phase: Phase 3 to Phase 4v8 Show 12 more changesShow less
    • Trial status: Suspended to Recruiting
    • Primary completion date: Mar 1, 2027 to Dec 2, 2027
    • Primary endpoints: 1 to 2
    • Enrollment target: 42 to 30
    • Study completion date: Mar 1, 2029 to Dec 2, 2028
    • Interventions: PRGN-2012 (Drug) to Zopapogene imadenovec (Zopa) (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 45 words
    • Site details revised at 3 of 3 sites
    • Study arms: 1 to 2
    • Study title expanded, about 1 word
  2. Trial status: Recruiting to Suspended Sponsor's reason: PAPZIMEOS (PRGN-2012; zopapogene imadenovec-drba) received full FDA-approval for the treatment of adults with RRP. As a result, the…
    • Site details revised at 3 of 3 sites
    v7
  3. Site contacts updated at 1 of 3 sitesv6
  4. Study sites: 2 to 3v5
  5. Site details revised at 2 of 2 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 2 of 2 sitesv3
  2. Site contacts updated at 1 of 2 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06538480
Lead Sponsor Precigen, Inc
Conditions
(from sponsor)		 Recurrent Respiratory Papillomatosis, Papillomavirus Infection, Papillomaviridae
Related terms Papillomavirus Infections, Recurrent respiratory papillomatosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov