NCT05060341

Brief 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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2020Mar 2027

Study Start

First participant enrolled

November 12, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

March 9, 2021

Last Update Submit

May 19, 2025

Conditions

Radiation-induced Xerostomia

Outcome Measures

Primary Outcomes (1)

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

    Safety

    4 years

Secondary Outcomes (4)

  • Changes in saliva flow compared to baseline.

    4 years

  • Changes in the McMaster Global Rate of Change relative to Baseline

    4 years

  • Changes in the Xerostomia Questionnaire relative to Baseline

    4 years

  • Changes in the MD Anderson Symptom Inventory - Head and Neck

    4 years

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with radiation induced parotid gland hypofunction and xerostomia who have particpated in the MGT016 AAV2hAQP1 study.

You may qualify if:

  • 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

You may not qualify if:

  • \. Subjects unwilling or unable to meet with the requirements of the study will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Leland Stanford Junior University

Stanford, California, 94305, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02184, United States

Location

Atrium Health

Charlotte, North Carolina, 28209, United States

Location

Health Sciences North - Northeast Cancer Center

Greater Sudbury, Ontario, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

September 29, 2021

Study Start

November 12, 2020

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(3)