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ENROLLING BY INVITATION
NCT06544798
PHASE2

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

Sponsor: MeiraGTx, LLC

View on ClinicalTrials.gov

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.

Official title: Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2024-08-02

Completion Date

2032-02

Last Updated

2025-10-16

Healthy Volunteers

No

Interventions

GENETIC

AAV2-hAQP1

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

Locations (8)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States

University of Iowa

Iowa City, Iowa, United States

University of Missouri

Columbia, Missouri, United States

Erie County Medical Center

Buffalo, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Alleghany General Hospital

Pittsburgh, Pennsylvania, United States

Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North

Greater Sudbury, Ontario, Canada