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To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALV003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALV003 | Drug | ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Intestinal mucosal morphometry | Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Intestinal intraepithelial lymphocyte density | Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells) | 12 weeks |
| Safety: safety and tolerability of ALV003 |
| Measure | Description | Time Frame |
|---|---|---|
| Celiac disease-specific serology | 12 weeks | |
| Quality of life | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Adelman, MD | Alvine Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Decatur | Alabama | 35601 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28755266 | Derived | Syage JA, Murray JA, Green PHR, Khosla C. Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. Dig Dis Sci. 2017 Sep;62(9):2428-2432. doi: 10.1007/s10620-017-4687-7. Epub 2017 Jul 28. | |
| 27864127 | Derived | Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Maki M, Adelman DC; CeliAction Study Group of Investigators. No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. Gastroenterology. 2017 Mar;152(4):787-798.e2. doi: 10.1053/j.gastro.2016.11.004. Epub 2016 Nov 15. |
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| placebo | Drug |
|
Incidence of adverse events between baseline and week 12
| 12 weeks |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Huntsville | Alabama | 35802 | United States |
| Scottsdale | Arizona | 85259 | United States |
| Scottsdale | Arizona | 85260 | United States |
| Tucson | Arizona | 85712 | United States |
| Los Angeles | California | 90025 | United States |
| Los Angeles | California | 90027 | United States |
| Modesto | California | 95355 | United States |
| Newport Beach | California | 92660 | United States |
| Oceanside | California | 92056 | United States |
| Orange | California | 92868 | United States |
| Palo Alto | California | 94301 | United States |
| Poway | California | 92064 | United States |
| Roseville | California | 95661 | United States |
| San Diego | California | 92114 | United States |
| San Jose | California | 95117 | United States |
| San Marcos | California | 92069 | United States |
| Aurora | Colorado | 80045 | United States |
| Bridgeport | Connecticut | 06606 | United States |
| Boynton Beach | Florida | 33426 | United States |
| Hollywood | Florida | 33021 | United States |
| Jacksonville | Florida | 32224 | United States |
| Jacksonville | Florida | 32256 | United States |
| Largo | Florida | 33777 | United States |
| Miami | Florida | 33137 | United States |
| Miami | Florida | 33165 | United States |
| Naples | Florida | 34102 | United States |
| Orlando | Florida | 32806 | United States |
| Atlanta | Georgia | 30328 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Meridian | Idaho | 83642 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60637 | United States |
| Evanston | Illinois | 60201 | United States |
| Oak Lawn | Illinois | 60453 | United States |
| Des Moines | Iowa | 50266 | United States |
| Topeka | Kansas | 66606 | United States |
| Baltimore | Maryland | 21229 | United States |
| Chevy Chase | Maryland | 20815 | United States |
| Boston | Massachusetts | 02215 | United States |
| Chesterfield | Michigan | 48047 | United States |
| Wyoming | Michigan | 49519 | United States |
| Rochester | Minnesota | 55905 | United States |
| Jackson | Mississippi | 39202 | United States |
| Kansas City | Missouri | 64131 | United States |
| Mexico | Missouri | 65265 | United States |
| Marlton | New Jersey | 08053 | United States |
| Great Neck | New York | 11023 | United States |
| New York | New York | 10032 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Rochester | New York | 14618 | United States |
| Asheville | North Carolina | 28801 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44122 | United States |
| Dayton | Ohio | 45415 | United States |
| Mentor | Ohio | 44060 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Portland | Oregon | 97225 | United States |
| Malvern | Pennsylvania | 19355 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15243 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Chattanooga | Tennessee | 37421 | United States |
| Hermitage | Tennessee | 37076 | United States |
| Houston | Texas | 77094 | United States |
| Irving | Texas | 75063 | United States |
| Southlake | Texas | 76092 | United States |
| West Jordan | Utah | 84088 | United States |
| Alexandria | Virginia | 22304 | United States |
| Virginia Beach | Virginia | 23454 | United States |
| Bellevue | Washington | 98004 | United States |
| Seattle | Washington | 98104 | United States |
| Madison | Wisconsin | 53705 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| Edmonton | Alberta | T6G 2X8 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Hamilton | Ontario | L8S 4K1 | Canada |
| Ottawa | Ontario | K2H 7B3 | Canada |
| Toronto | Ontario | M9C 4Z5 | Canada |
| Tampere | Finland |
| Galway | Ireland |
| Oslo | Norway |
| Sheffield | S11 7FF | United Kingdom |
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C571240 | ALV003 |
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