Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia

NCT05060341 · tracked via the Priya Life Science USA tracker

Sponsor

MeiraGTx, LLC

Phase

Observational

Started

2020-11-12

Last updated

2026-07-22

Condition(s) studied

Radiation-induced Xerostomia

Study summary

This study is a long-term follow-up study for patients who have been administered AAV2hAQP1 in the Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity in Subjects with Radiation Induced Parotid Gland Hypofunction and Xerostomia

Eligibility

Sex

ALL

Min age

18 Years

Max age

81 Years

Healthy volunteers

Inclusion Criteria: 1. Are willing and able to provide informed consent 2. Received AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in the prior open-label, Phase 1, dose-escalation study (Study MGT016) 3. Are willing and able to adhere to the protocol and long-term follow-up Exclusion Criteria: 1\. Subjects unwilling or unable to meet with the requirements of the study will be excluded

Primary outcome measure(s)

• Incidence of AEs, treatment-emergent adverse events (TEAEs), and SAEs — 4 years
Safety

Trial sites (4)

Facility	City	Region
Leland Stanford Junior University	Stanford	California
Brigham and Women's Hospital	Boston	Massachusetts
Atrium Health	Charlotte	North Carolina
Health Sciences North - Northeast Cancer Center	Greater Sudbury	Ontario

More MeiraGTx, LLC trials in the USA

Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease Active, not recruiting

A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia Active, not recruiting

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05060341 on ClinicalTrials.gov ↗ ← All trials in the USA