Active — Not RecruitingNot Applicable

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

United States, Canada22 participantsStarted 2020-11-12

Plain-language 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

Who can participate

Age range18 Years – 81 Years

SexALL

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Inclusion criteria

✓. Are willing and able to provide informed consent
✓. 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)
✓. Are willing and able to adhere to the protocol and long-term follow-up

What they're measuring

• Incidence of AEs, treatment-emergent adverse events (TEAEs), and SAEs

Timeframe: 4 years

Trial details

NCT IDNCT05060341

SponsorMeiraGTx, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Radiation-induced Xerostomia trials