Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia
NCT ID: NCT05060341
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
22 participants
OBSERVATIONAL
2020-11-12
2027-03-31
Brief Summary
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Detailed Description
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After completion of their Month 12 Follow-Up visit in Study MGT016, subjects will be invited to enroll in this 4-year follow-up study during which they will be assessed for up to 60 months following study drug administration. This follow-up trial is a non-interventional study designed to collect data on longer-term safety and activity at 18, 24, 36, 48, and 60 months following study drug administration.
Over the course of the study, subjects will undergo physical and oral examinations; vital sign measurements; weight measurements; AE assessments; concurrent medication assessments; sample blood collection for hematology and chemistry; urinalysis; ear, nose, and throat (ENT) screening for malignancy; imaging assessments (if indicated); salivary flow assessments; and questionnaire assessments.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
2. Received AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in the prior open-label, Phase 1, dose-escalation study (Study MGT016)
3. Are willing and able to adhere to the protocol and long-term follow-up
Exclusion Criteria
18 Years
81 Years
ALL
No
Sponsors
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MeiraGTx, LLC
INDUSTRY
Responsible Party
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Locations
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Leland Stanford Junior University
Stanford, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Atrium Health
Charlotte, North Carolina, United States
Health Sciences North - Northeast Cancer Center
Greater Sudbury, Ontario, Canada
Countries
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Other Identifiers
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MGT-AQP1-102
Identifier Type: -
Identifier Source: org_study_id
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