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
Public ClinicalTrials.gov record NCT04043104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands: To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Study identification
- NCT ID
- NCT04043104
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Interventions
- AAV2hAQP1: 1 x 10^11 vg/gland (single gland) Drug
- AAV2hAQP1: 3 x 10^10 vg/gland (both glands) Drug
- AAV2hAQP1: 3 x 10^11 vg/gland (single gland) Drug
- AAV2hAQP1: 1 x 10^11 vg/gland (both glands) Drug
- AAV2hAQP1: 1 x 10^12 vg/gland (single gland) Drug
- AAV2hAQP1: 3 x 10^11 vg/gland (both glands) Drug
- AAV2hAQP1: 3 x 10^12 vg/gland (single gland) Drug
- AAV2hAQP1: 1 x 10^12 vg/gland (both glands) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 29, 2019
- Primary completion
- Mar 27, 2023
- Completion
- Mar 27, 2023
- Last update posted
- Apr 23, 2023
2019 – 2023
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Leland Stanford Junior University | Stanford | California | 94305 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02184 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Atrium Health | Charlotte | North Carolina | 28209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04043104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04043104 live on ClinicalTrials.gov.