Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
Phase 2
- Conditions
- Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
- Registration Number
- NCT06544798
- Lead Sponsor
- MeiraGTx, LLC
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Received study drug in Study MGT-AQP1-201
Exclusion Criteria
- Withdrew consent to participate in Study MGT-AQP1-201.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants with study drug-related adverse events and serious adverse events From study start until Month 60 post-treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Atrium Health🇺🇸Charlotte, North Carolina, United States