Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Conditions
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 in Study MGT-AQP1-202.
Interventions
GENETICAAV2-hAQP1
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland
Sponsors
MeiraGTx, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received study drug in Study MGT-AQP1-201
Exclusion criteria
* Withdrew consent to participate in Study MGT-AQP1-201.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with study drug-related adverse events and serious adverse events | From study start until Month 60 post-treatment |
Countries
Canada, United States
Outcome results
None listed