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Virus Therapy

1 x 10^12 vg/gland (single gland) for Parotid Gland Hypofunction

Phase 1

Waitlist Available

Research Sponsored by MeiraGTx UK II Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one day to one year

Awards & highlights

Study Summary

This trial is testing a gene therapy to treat radiation-induced xerostomia, or dry mouth. The objective is to find the maximum safe dose and to see if the therapy improves symptoms and increases saliva output.

Eligible Conditions

Radiation-Induced Parotid Gland Hypofunction
Head and Neck Cancers
Dry Mouth

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one day to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one day to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one day to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The is safety of AAV2hAQP1 administered to the parotid gland of adult subjects with radiation-induced xerostomia

Trial Design

8Treatment groups

Experimental Treatment

Group I: 3 x 10^12 vg/gland (single gland)Experimental Treatment1 Intervention

Group II: 3 x 10^11 vg/gland (single gland)Experimental Treatment1 Intervention

Group III: 3 x 10^11 vg/gland (both glands)Experimental Treatment1 Intervention

Group IV: 3 x 10^10 vg/gland (both glands)Experimental Treatment1 Intervention

Group V: 1 x 10^12 vg/gland (single gland)Experimental Treatment1 Intervention

Group VI: 1 x 10^12 vg/gland (both glands)Experimental Treatment1 Intervention

Group VII: 1 x 10^11 vg/gland (single gland)Experimental Treatment1 Intervention

Group VIII: 1 x 10^11 vg/gland (both glands)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AAV2hAQP1: 1 x 10^12 vg/gland (single gland)

2019

Completed Phase 1

~30

AAV2hAQP1: 1 x 10^11 vg/gland (both glands)

2019

Completed Phase 1

~30

AAV2hAQP1: 3 x 10^11 vg/gland (single gland)

2019

Completed Phase 1

~30

AAV2hAQP1: 3 x 10^11 vg/gland (both glands)

2019

Completed Phase 1

~30

AAV2hAQP1: 3 x 10^12 vg/gland (single gland)

2019

Completed Phase 1

~30

AAV2hAQP1: 1 x 10^12 vg/gland (both glands)

2019

Completed Phase 1

~30

AAV2hAQP1: 3 x 10^10 vg/gland (both glands)

2019

Completed Phase 1

~30

AAV2hAQP1: 1 x 10^11 vg/gland (single gland)

2019

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MeiraGTx UK II LtdLead Sponsor

14 Previous Clinical Trials

697 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what locations can participants access this clinical trial?

"Five medical centers are currently running the trial, three of which are located in Louisville, Charlotte and Sudbury. To reduce travel fatigue, it is highly recommended to find a site closest to you if deciding to participate."

Answered by AI

Has the Food and Drug Administration approved the intraductal injection of AAV2hAQP1?

"Our internal assessment of the safety profile for this trial, which is at Phase 1 and therefore has limited data validation its effectiveness and safety, resulted in a score of 1."

Answered by AI

Is there still a window of opportunity for individuals to enrol in this trial?

"Per the information on clinicaltrials.gov, this medical study is no longer accepting participants as of May 3rd 2022. Initially posted on June 30th 2019, the trial has completed its recruitment phase while there are 310 other trials actively recruiting volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia

2019. "A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04043104.