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

Last updated: May 19, 2025
Sponsor: MeiraGTx, LLC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Saliva And Salivary Gland Dysfunction

Dry Mouth

Treatment

N/A

Clinical Study ID

NCT05060341
MGT-AQP1-102
  • Ages 18-81
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Are willing and able to provide informed consent

  2. Received AAV2hAQP1 administered via Stensen's duct to a single or both parotidglands 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

Exclusion Criteria:

  1. Subjects unwilling or unable to meet with the requirements of the study will beexcluded

Study Design

Total Participants: 22
Study Start date:
November 12, 2020
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Health Sciences North - Northeast Cancer Center

    Sudbury, Ontario
    Canada

    Site Not Available

  • Leland Stanford Junior University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02184
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28209
    United States

    Site Not Available

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