Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
NCT ID: NCT06544798
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
276 participants
INTERVENTIONAL
2024-08-02
2032-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Follow-up group
Participants who were randomized to AAV2-hAQP1 treatment in Study MGT-AQP1-201 will continue in this long-term follow-up schedule to complete an additional 48 months of follow-up after their end-of-study visit in Study MGT-AQP1-201. All study participants are to be followed for a period of 60 months after vector administration.
No interventions assigned to this group
Active treatment group
Participants who were randomized to placebo treatment in Study MGT-AQP1-201, will be offered to transition from the long-term follow-up schedule to an active treatment schedule at the time of unblinding. Study drug administration should be completed after unblinding and after confirmation of the participant's continued eligibility for treatment. Upon completion of the 12-month primary treatment period, participants will continue in the study according to a follow-up schedule, to complete a total of 60 months of follow-up after AAV2-hAQP1 administration.
AAV2-hAQP1
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland
Interventions
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AAV2-hAQP1
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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MeiraGTx, LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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MGT-AQP1-202
Identifier Type: -
Identifier Source: org_study_id
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