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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
290
Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Administration of diluent via Stensen's duct to each parotid gland
Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score
The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80.
Time frame: 12 months
Change from Baseline to Month 12 in unstimulated whole saliva flow rate
Change from Baseline to Month 12 in unstimulated whole saliva flow rate (mL/min)
Time frame: 12 months
The number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: from Baseline to Month 12
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Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland
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...and 23 more locations