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NCT02446249 · ClinicalTrials.gov registry record · Phase 1
Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary Hypofunction
A Phase 1 study of Radiation-induced Xerostomia and Squamous Cell Head and Neck Cancer, sponsored by MeiraGTx.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT02446249 is a Phase 1 study of Radiation-induced Xerostomia and Squamous Cell Head and Neck Cancer that is active but no longer recruiting, run by MeiraGTx. The registered enrollment target is 17 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02446249, a Phase 1 study of Radiation-induced Xerostomia and Squamous Cell Head and Neck Cancer, is active but no longer recruiting, sponsored by MeiraGTx.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can cause problems like infections and tooth decay. Researchers hope a new drug can help people with dry mouth caused by radiation. Objectives: \- To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in people whose parotid glands have had radiation. Eligibility: \- People at least 18 years of age with a history of radiation therapy for head and neck cancer. Design: Participants will be screened in 2 visits with: * medical history * physical exam * scans of the head, neck, and chest * intravenous administration of glycopyrrolate to stop saliva * saliva collections * sialogram which is a procedure in which a substance is injected in the parotid gland and X-rays are taken. * non-drug infusion * a small piece of skin being taken 3-5-day hospital stay: Participants will receive the gene infusion. The AAV2hAQP1 will be in a solution in a syringe. It will be slowly pushed into the parotid gland through the parotid duct, an opening in the mouth near the second upper molar tooth. 10 outpatient visits over 3 years. These may include: * repeats of selected screening tests, including saliva collection * blood and urine tests * oral and dental examinations * head and neck exams, including the use of a thin scope to see the back of the throat * questionnaires * a small piece of parotid tissue being taken by either a small scope through the parotid duct or by a small needle guided by ultrasound * scans of the head and neck. For some, contrast will be injected in a vein * completion of a diary about how the participant feels between visits * swabs of teeth and gums to assess the microbiome of the mouth
Conditions Studied
Interventions
- BIOLOGICAL AAV2hAQP1
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-05-04 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02446249
The ClinicalTrials.gov registry entry for NCT02446249 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MeiraGTx, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Radiation-induced Xerostomia appearing as the primary indexed condition, and to 1 intervention - of which AAV2hAQP1 is the first listed.
NCT02446249 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02446249 about?
NCT02446249 is a clinical study titled "Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary Hypofunction". Background: \- Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can cause problems like infections and tooth decay. Researchers hope a new drug can help people with dry mouth caused by radiation. Objectives: \- To examine the safety of AAV2hAQP1 gene therapy. ...
What is the current status of trial NCT02446249?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2015-05-04. Estimated completion is 2026-07.
What conditions does trial NCT02446249 study?
This clinical trial studies the following conditions: Radiation-induced Xerostomia, Squamous Cell Head and Neck Cancer, Salivary Hypofunction.
What interventions are being tested in trial NCT02446249?
The interventions under investigation include: AAV2hAQP1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02446249?
This trial is sponsored by MeiraGTx, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02446249 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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