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A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

NCT05926765 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-02-02

No results posted yet for this 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

  • Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands

Interventions

GENETIC

AAV2-hAQP1 Concentration 1

Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland

GENETIC

AAV2-hAQP1 Concentration 2

Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland

OTHER

Placebo

Administration of diluent via Stensen's duct to each parotid gland

GENETIC

AAV2-hAQP1 Concentration 3

Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland

GENETIC

AAV2-hAQP1 Concentration 4

Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland

Sponsors & Collaborators

  • MeiraGTx, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926765 on ClinicalTrials.gov