NCT05060341

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: MeiraGTx, LLC · Industry
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: —

Summary

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

Detailed description

This clinical trial is designed to assess the long-term safety and activity of intra-parotid administration of AAV2hAQP1 in subjects with radiation-induced parotid salivary hypofunction and xerostomia. 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

• Radiation-induced Xerostomia

Timeline

• Start date: 2020-11-12
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2021-09-29
• Last updated: 2025-05-22

Locations

4 sites across 2 countries: United States, Canada