- Protocol No.
- PSCI-25-083
- Prinicipal Investigator
- Goyal, Neerav
- Phase
- Phase II
- Age Group
- Adult
- Scope
- National
- Title
- Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia- MGT-AQP1-202
- Objective
- Primary: To evaluate the long-term safety of AAV2-hAQP1 in participants with radiation-induced late xerostomia
Secondary: To assess the effect of bilateral treatment with AAV2-hAQP1 on xerostomia symptoms as measured by patient-reported outcome assessments
To assess the effect of bilateral treatment with AAV2-hAQP1 on unstimulated whole saliva output (mL/min)
Exploratory: To evaluate any changes in stimulated whole saliva output (mL/min) after bilateral treatment with AAV2-hAQP1
To evaluate any changes in oral wetness after bilateral treatment with AAV2-hAQP1.
- Applicable Disease Sites
- Head and Neck
- Status
- Open
- Participating Institutions
- Hershey Medical Center
