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NCT04724980 · ClinicalTrials.gov registry record · Phase 1
Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis
A Phase 1 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infections, sponsored by Precigen.
- Active
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04724980: Active Phase 1 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infections, sponsored by Precigen.
NCT04724980 is a Phase 1 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infections that is active but no longer recruiting, run by Precigen. The registered enrollment target is 38 participants, above the 32-participant average among 6 other Recurrent Respiratory Papillomatosis trials with a reported enrollment target (19% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04724980, a Phase 1 study of Recurrent Respiratory Papillomatosis and Papillomavirus Infections, is active but no longer recruiting, sponsored by Precigen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.
Primary Outcome
A complete response is defined as no requirement for surgical intervention in the 12 months after treatment
Conditions Studied
Interventions
- DRUG PRGN-2012 - Phase I; Dose Level 1
- DRUG PRGN-2012 - Phase I; Dose Level 2
- DRUG PRGN-2012 - Phase II; Dose Level 2
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2026-06-05 |
| Phase | Phase 1 |
What the registry record for NCT04724980 still lists
NCT04724980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, above the 32-participant average among 6 other Recurrent Respiratory Papillomatosis trials with a reported enrollment target (19% higher).
The record links to 3 conditions, with Recurrent Respiratory Papillomatosis appearing as the primary indexed condition, and to 3 interventions - of which PRGN-2012 - Phase I; Dose Level 1 is the first listed.
NCT04724980 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04724980 about?
NCT04724980 is a clinical study titled "Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis". This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a ...
What is the current status of trial NCT04724980?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2021-03-16. Estimated completion is 2026-06-05.
What conditions does trial NCT04724980 study?
This clinical trial studies the following conditions: Recurrent Respiratory Papillomatosis, Papillomavirus Infections, Papillomaviridae.
What interventions are being tested in trial NCT04724980?
The interventions under investigation include: PRGN-2012 - Phase I; Dose Level 1 (DRUG), PRGN-2012 - Phase I; Dose Level 2 (DRUG), PRGN-2012 - Phase II; Dose Level 2 (DRUG).
Who is sponsoring clinical trial NCT04724980?
This trial is sponsored by Precigen, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04724980 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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