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Trial Title:
Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
NCT ID:
NCT06544798
Condition:
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Conditions: Official terms:
Xerostomia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be assigned to the follow-up group or active treatment group based on
the group to which they were randomized in Study MGT-AQP1-201.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
AAV2-hAQP1
Description:
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each
parotid gland
Arm group label:
Active treatment group
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 in Study MGT-AQP1-202.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Received study drug in Study MGT-AQP1-201
Exclusion Criteria:
- Withdrew consent to participate in Study MGT-AQP1-201.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Atrium Health
Address:
City:
Charlotte
Zip:
28209
Country:
United States
Start date:
August 2, 2024
Completion date:
February 2031
Lead sponsor:
Agency:
MeiraGTx, LLC
Agency class:
Industry
Source:
MeiraGTx UK II Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06544798
