MedTrace Logo

Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia

NCT06544798 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-10-16

No results posted yet for this study

Summary

This study will assess the long-term safety and efficacy 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

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

Sponsors & Collaborators

  • MeiraGTx, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2032-02-29
Completion
2032-02-29
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT06544798 on ClinicalTrials.gov