Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

MeiraGTx, LLC

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.

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Received study drug in Study MGT-AQP1-201 Exclusion Criteria: * Withdrew consent to participate in Study MGT-AQP1-201.

Interventions

Genetic
AAV2-hAQP1
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland

Locations (8)

Banner MD Anderson Cancer Center
Gilbert, Arizona
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida
University of Iowa
Iowa City, Iowa
University of Missouri
Columbia, Missouri
Erie County Medical Center
Buffalo, New York
Atrium Health
Charlotte, North Carolina