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This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.
Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months. Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic visits.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APT-1011 3 mg HS | Drug | APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient. |
|
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Del Sol Research Management LLC | Tucson | Arizona | 85715 | United States | ||
| Arkansas Gastroenterology |
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| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| Ventura County Gastroenterology Medical Group Camarillo | Camarillo | California | 93012 | United States |
| FOMAT Medical Research | Glendale | California | 91204 | United States |
| United Medical Doctors | Murrieta | California | 92563 | United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| Western States Clinical Research Inc | Wheat Ridge | Colorado | 80033 | United States |
| Nuvance Health Medical Practice Ct, Inc. | Danbury | Connecticut | 06810 | United States |
| Medical Research Center of Connecticut | Hamden | Connecticut | 06518-3694 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Endoscopic Research, Inc. | Orlando | Florida | 32803 | United States |
| Summit Clinical Research | Athens | Georgia | 30607 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| MGG Group Co., Inc. | Chevy Chase | Maryland | 20815 | United States |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | United States |
| Boston Specialists | Boston | Massachusetts | 02111 | United States |
| Clinical Research Institute of Michigan LLC | Chesterfield | Michigan | 48047 | United States |
| Henry Ford Health System | Novi | Michigan | 48377 | United States |
| West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | United States |
| MNGI Digestive Health, P.A. | Minneapolis | Minnesota | 55413 | United States |
| Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic | Plymouth | Minnesota | 55446 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Bozeman Health Clinical Research | Bozeman | Montana | 59715 | United States |
| Clinical and Translational Research Center (CTRC) | Chapel Hill | North Carolina | 27599 | United States |
| Carolina Research | Greenville | North Carolina | 27834 | United States |
| Gastro Health Research | Cincinnati | Ohio | 45219 | United States |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45236 | United States |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | United States |
| Northshore Gastroenterology Research LLC | Westlake | Ohio | 44145 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Regional Gastroenterology Associates of Lancaster, Ltd. | Wyomissing | Pennsylvania | 19610 | United States |
| Rapid City Medical Center LLP | Rapid City | South Dakota | 57701 | United States |
| GI Alliance | Garland | Texas | 75044 | United States |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000710607 | APT-1011 |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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