AAV2hAQP1 for Dry Mouth
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is a long-term follow-up study for a treatment called AAV2hAQP1, administered to individuals experiencing dry mouth due to radiation therapy. The research aims to assess the long-term safety and effectiveness of AAV2hAQP1 for those who participated in an earlier study. It specifically targets individuals who received this treatment in a previous study and are willing to continue monitoring. Participants must have had AAV2hAQP1 administered to their salivary glands in the past study and be prepared to adhere to the follow-up schedule. As a Phase 4 trial, this study focuses on understanding how the already FDA-approved treatment benefits more patients, offering participants a chance to contribute to broader knowledge of its long-term effects.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What is the safety track record for AAV2hAQP1?
Research has shown that AAV2hAQP1 has been tested for safety in people with salivary glands damaged by radiation. One study found that delivering AAV2hAQP1 directly to the parotid glands (the salivary glands near the mouth) increased fluid production, indicating the treatment was working as expected.
Studies are evaluating the long-term safety of AAV2hAQP1, following patients for several years, up to 60 months after treatment. Initial studies reported no serious safety issues. However, since the treatment is still in the early stages of testing, ongoing monitoring is necessary to ensure it remains safe over time.
For those considering joining a trial, it's important to know that while early results are promising, researchers are still collecting data to confirm long-term safety.12345Why are researchers enthusiastic about this study treatment?
Most treatments for radiation-induced xerostomia, or dry mouth, focus on managing symptoms with saliva substitutes, medications that stimulate saliva production, or palliative care. But AAV2hAQP1 works differently. It involves gene therapy using an adeno-associated virus (AAV) to deliver the aquaporin-1 (AQP1) gene directly to the salivary glands. This innovative approach aims to restore the glands' ability to produce saliva naturally, offering a potential long-term solution rather than just temporary relief. Researchers are excited because this method could significantly improve the quality of life for those affected by this condition.
What evidence suggests that AAV2hAQP1 might be an effective treatment for radiation-induced parotid gland hypofunction and xerostomia?
Research has shown that AAV2hAQP1 may help treat dry mouth caused by radiation therapy. In studies with minipigs, this treatment restored saliva flow in damaged salivary glands without causing harm. Human patients reported significant relief from dry mouth symptoms after receiving AAV2hAQP1. The treatment delivers a gene that enables the remaining cells in the salivary glands to produce more fluid, reducing dryness. Overall, early evidence suggests AAV2hAQP1 could be effective for this condition.12467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Follow-up
Participants complete their Month 12 Follow-Up visit in Study MGT016
Long-Term Follow-up
Participants are assessed for long-term safety and activity at 18, 24, 36, 48, and 60 months following study drug administration
What Are the Treatments Tested in This Trial?
Interventions
- AAV2hAQP1
Find a Clinic Near You
Who Is Running the Clinical Trial?
MeiraGTx UK II Ltd
Lead Sponsor
MeiraGTx, LLC
Lead Sponsor
Citations
Safety of a Single Administration of AAV2hAQP1, an Adeno ...
Minipig studies have shown that the AAV2hAQP1 strategy for restoring salivary flow to IR-damaged salivary glands is effective without untoward effects after ...
2.
investors.meiragtx.com
investors.meiragtx.com/news-releases/news-release-details/meiragtx-announces-positive-clinical-data-aquax-phase-1-0Investors & Media
The data demonstrate clinically important improvements in two different patient reported outcome questionnaires for xerostomia, as well as meaningful increases ...
AAV2-mediated transfer of the human aquaporin-1 cDNA ...
The findings demonstrate that localized delivery of AAV2hAQP1 to IR-damaged parotid glands leads to increased fluid secretion from surviving duct cells.
A Phase 1 Open-Label, Dose Escalation Study to ...
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 ...
Long-Term Follow-Up Study of AAV2hAQP1 for Radiation ...
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 ...
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05060341/long-term-follow-up-study-of-aav2haqp1-for-radiation-induced-xerostomiaLong-Term Follow-Up Study of AAV2hAQP1 for Radiation ...
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 ...
7.
go.drugbank.com
go.drugbank.com/drugs/DB17417/clinical_trials?conditions=DBCOND0042625%2CDBCOND0121802%2CDBCOND0105768&phase=1&purpose=treatment&status=completedAAV-AQP1 Completed Phase 1 Trials for Radiation- ...
NCT04043104. A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced ...
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