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A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Sponsor: MeiraGTx, LLC
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
AAV2-hAQP1 Concentration 1
Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
AAV2-hAQP1 Concentration 2
Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Placebo
Administration of diluent via Stensen's duct to each parotid gland
AAV2-hAQP1 Concentration 3
Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland
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