Status:
ENROLLING_BY_INVITATION
Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
Lead Sponsor:
MeiraGTx, LLC
Conditions:
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 i...
Eligibility Criteria
Inclusion
- Received study drug in Study MGT-AQP1-201
Exclusion
- Withdrew consent to participate in Study MGT-AQP1-201.
Key Trial Info
Start Date :
August 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2032
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06544798
Start Date
August 2 2024
End Date
February 1 2032
Last Update
October 16 2025
Active Locations (8)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States, 33176
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
University of Missouri
Columbia, Missouri, United States, 65212