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RECRUITING
NCT05926765
PHASE2

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

Sponsor: MeiraGTx, LLC

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety 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

2023-06-13

Completion Date

2026-12

Last Updated

2026-02-02

Healthy Volunteers

No

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

Locations (33)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Health

Detroit, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Washington University - St. Louis

St Louis, Missouri, United States

Erie County Medical Center

Buffalo, New York, United States

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health

Charlotte, North Carolina, United States

Penn State

Hershey, Pennsylvania, United States

Alleghany General Hospital

Pittsburgh, Pennsylvania, United States

Johnson City Medical Center

Johnson City, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist

Houston, Texas, United States

Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North

Greater Sudbury, Ontario, Canada

Hopital Fleurimont, CIUSSS de l'Estrie-CHUS

Québec, Canada

Princess Margaret Cancer Centre

Toronto, Canada

CIUSSS-MCQ (Trois-Rivières, QC)

Trois-Rivières, Canada

Addenbrooke's Hospital

Cambridge, United Kingdom

Cardiff and Vale NHS Trust - Head & Neck Services

Cardiff, United Kingdom

Ninewells Hospital & Medical School

Dundee, United Kingdom

Glasgow Royal Infirmary

Glasgow, United Kingdom

Leeds Dental Institute

Leeds, United Kingdom

Western General

London, United Kingdom

Guys Hospital

London, United Kingdom

The Royal Marsden

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

York Hospital

York, United Kingdom