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AAV2hAQP1

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

Ensayo de MeiraGTx Holdings plc en Squamous Cell Head and Neck Cancer · Radiation Induced Xerostomia · Salivary Hypofunction (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

17

previstos

Centros

1

Fin del objetivo primario

ago 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2015.

Qué mide

Safety of vector (del registro, en inglés) (36 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroBackground: \- 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

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Ficha completa en ClinicalTrials.gov (NCT02446249), actualizada en ago 2026.