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This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: AAV2-hAQP1 Group 1 | Experimental | Eligible participants will receive up to 3 mL of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
|
| Cohort 1: AAV2-hAQP1 Group 2 | Experimental | Eligible participants will receive up to 3 mL of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
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| Cohort 1: Placebo group | Placebo Comparator | Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland |
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| Cohort 2: AAV2-hAQP1 Group 3 | Experimental | Eligible participants will receive up to 3 mL of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
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| Cohort 2: AAV2-hAQP1 Group 4 | Experimental | Eligible participants will receive up to 3 mL of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAV2-hAQP1 Concentration 1 | Genetic | Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score | The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Month 12 in unstimulated whole saliva flow rate | Change from Baseline to Month 12 in unstimulated whole saliva flow rate (mL/min) | 12 months |
| The number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MeiraGTx Clinical Project Manager | Contact | 646-860-7982 | MGT-AQP1-201@meiragtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States |
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| Cohort 2 Placebo group | Placebo Comparator | Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland |
|
| AAV2-hAQP1 Concentration 2 | Genetic | Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
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| Placebo | Other | Administration of diluent via Stensen's duct to each parotid gland |
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| AAV2-hAQP1 Concentration 3 | Genetic | Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
|
| AAV2-hAQP1 Concentration 4 | Genetic | Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
|
| from Baseline to Month 12 |
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| Miami Cancer Institute at Baptist Health South Florida | Recruiting | Miami | Florida | 33176 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21231 | United States |
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| Tufts University School of Dental Medicine | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02120 | United States |
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| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
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| Washington University - St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
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| Erie County Medical Center | Recruiting | Buffalo | New York | 14215 | United States |
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| UNC-Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Atrium Health | Recruiting | Charlotte | North Carolina | 28203 | United States |
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| Penn State | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Alleghany General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| Johnson City Medical Center | Recruiting | Johnson City | Tennessee | 37604 | United States |
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| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Houston Methodist | Recruiting | Houston | Texas | 77030 | United States |
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| Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North | Recruiting | Greater Sudbury | Ontario | P3E 5J1 | Canada |
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| Hopital Fleurimont, CIUSSS de l'Estrie-CHUS | Recruiting | Québec | J1H 5HE | Canada |
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| Princess Margaret Cancer Centre | Recruiting | Toronto | M5G 2C4 | Canada |
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| CIUSSS-MCQ (Trois-Rivières, QC) | Recruiting | Trois-Rivières | G8Z 3R9 | Canada |
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| Addenbrooke's Hospital | Recruiting | Cambridge | United Kingdom |
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| Cardiff and Vale NHS Trust - Head & Neck Services | Recruiting | Cardiff | CF14 4XW | United Kingdom |
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| Ninewells Hospital & Medical School | Recruiting | Dundee | DD1 9SY | United Kingdom |
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| Glasgow Royal Infirmary | Recruiting | Glasgow | LS2 9LU | United Kingdom |
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| Leeds Dental Institute | Recruiting | Leeds | LS2 9LU | United Kingdom |
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| Western General | Recruiting | London | EH4 2XU | United Kingdom |
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| Guys Hospital | Recruiting | London | SE1 9RT | United Kingdom |
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| The Royal Marsden | Recruiting | London | SW3 6JJ | United Kingdom |
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| University College London Hospitals NHS Foundation Trust | Recruiting | London | WC1E 6DG | United Kingdom |
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| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | NG7 2UH | United Kingdom |
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| York Hospital | Recruiting | York | YO31 8HE | United Kingdom |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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