Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia

Trial ID or NCT#

NCT05060341

Status

recruiting iconRECRUITING

Purpose

This study is a long-term follow-up study for patients who have been administered AAV2hAQP1 in the Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity in Subjects with Radiation Induced Parotid Gland Hypofunction and Xerostomia

Official Title

Long-Term Follow-Up Study of Participants Enrolled in the MGT016 Phase 1, Open-Label, Dose-Escalation Study of AAV2hAQP1 for Radiation-Induced Parotid Gland Hypofunction and Xerostomia

Eligibility Criteria

Ages Eligible for Study: 18 Years to 81 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Are willing and able to provide informed consent 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:
  1. 1. Subjects unwilling or unable to meet with the requirements of the study will be excluded
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Investigator(s)

Dyani Gaudilliere
Dyani Gaudilliere
Dental surgeon
Clinical Associate Professor, Surgery - Plastic & Reconstructive Surgery

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Contact

Somayeh H. Ahmad
650-441-0405

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View on ClinicalTrials.gov