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NCT05926765 · ClinicalTrials.gov registry record · Phase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
A Phase 2 study of Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands, sponsored by MeiraGTx.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 276
- Enrollment target
- 20
- Study locations
NCT05926765: Recruiting Phase 2 study of Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands, sponsored by MeiraGTx.
NCT05926765 is a Phase 2 study of Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands that is actively recruiting participants, run by MeiraGTx. The registered enrollment target is 276 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05926765, a Phase 2 study of Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands, is actively recruiting participants, sponsored by MeiraGTx.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 276 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
Primary Outcome
The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80.
Conditions Studied
Interventions
- OTHER Placebo
- GENETIC AAV2-hAQP1 Concentration 1
- GENETIC AAV2-hAQP1 Concentration 2
- GENETIC AAV2-hAQP1 Concentration 3
- GENETIC AAV2-hAQP1 Concentration 4
Study Locations (20)
Massachusetts
- Tufts University School of Dental Medicine - Boston
- Brigham and Women's Hospital - Boston
Missouri
- University of Missouri - Columbia
- Washington University - St. Louis - St Louis
North Carolina
- UNC-Chapel Hill - Chapel Hill
- Atrium Health - Charlotte
Pennsylvania
- Penn State - Hershey
- Alleghany General Hospital - Pittsburgh
Texas
- UT Southwestern Medical Center - Dallas
- Houston Methodist - Houston
Arizona
- Banner MD Anderson Cancer Center - Gilbert
California
- City of Hope - Duarte
Florida
- Miami Cancer Institute at Baptist Health South Florida - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2023-06-13 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05926765 shows while recruiting
NCT05926765 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher).
The record links to 1 condition, with Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT05926765 names 20 study sites across 15 states, led by Massachusetts, Missouri, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05926765 about?
NCT05926765 is a clinical study titled "A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia". This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
What is the current status of trial NCT05926765?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 276 participants. The study started on 2023-06-13. Estimated completion is 2026-12.
What conditions does trial NCT05926765 study?
This clinical trial studies the following conditions: Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands.
What interventions are being tested in trial NCT05926765?
The interventions under investigation include: Placebo (OTHER), AAV2-hAQP1 Concentration 1 (GENETIC), AAV2-hAQP1 Concentration 2 (GENETIC), AAV2-hAQP1 Concentration 3 (GENETIC), AAV2-hAQP1 Concentration 4 (GENETIC).
Who is sponsoring clinical trial NCT05926765?
This trial is sponsored by MeiraGTx, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05926765 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05926765's enrollment target sits among peer trials
276 202nd of 2000 higher than 1,799 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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