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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 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. The trial reports 20 study locations across 15 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05926765
The ClinicalTrials.gov registry entry for NCT05926765 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MeiraGTx, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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