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For business consideration, a new long-term safety study will be conducted in the next new pivotal studies.
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The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP-671 | Experimental |
| |
| Allopurinol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-671 | Drug | Participants who were randomized to any of the ABP-671 treatment groups in Part 1 or Part 2 of Study ABP-671-301 will continue to receive the same dose level and dosing regimen during the Treatment Period of this Extension Study. Participants who were randomized to receive placebo in Part 1 or Part 2 of Study ABP-671-301 will receive ABP-671 during the Treatment Period of the Extension Study. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) | Week 26 | |
| Incidence of treatment-emergent adverse events (Safety and Tolerability) | Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) | Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research | Tempe | Arizona | 85281 | United States | ||
| Tucson Neuroscience Research, LLC |
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|
| Allopurinol | Drug | Participants who were randomized to receive allopurinol in Part 1 of Study ABP-671-301 will continue to receive allopurinol during the Treatment Period of the Extension Study. |
|
| Tucson |
| Arizona |
| 85710 |
| United States |
| Anaheim Clinical Trials (Cenexel ACT) | Anaheim | California | 92801 | United States |
| Center for Clinical Trials of Sacramento | Sacramento | California | 95823 | United States |
| Access Research Institute | Brooksville | Florida | 34613 | United States |
| Nature Coast Clinical Reasearch | Crystal River | Florida | 34429 | United States |
| JY Research Institute Inc. | Cutler Bay | Florida | 33189 | United States |
| Accel Clinical Research Site | DeLand | Florida | 32720 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| A & D Doctor Center | Miami | Florida | 33135 | United States |
| Bioclinical Research Alliance | Miami | Florida | 33155 | United States |
| Cordova Research Institute | Miami | Florida | 33155 | United States |
| Century Research LLC | Miami | Florida | 33173 | United States |
| ITB Research | Miami | Florida | 33173 | United States |
| Combined Research Orlando Phase I-IV | Orlando | Florida | 32807 | United States |
| New Horizons Research | Palmetto Bay | Florida | 33158 | United States |
| Advanced Clinical Research of Atlanta | Atlanta | Georgia | 30309 | United States |
| Centricity Research | Columbus | Georgia | 31904 | United States |
| Alliance for Multispecialty Research, LLC. | Newton | Kansas | 67114 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| AMR | New Orleans | Louisiana | 70119 | United States |
| Annapolis Internal Medicine/CCT Research | Annapolis | Maryland | 21401 | United States |
| DelRicht Research of Gulfport | Gulfport | Mississippi | 39501 | United States |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | United States |
| Santa Rosa Medical Center | Las Vegas | Nevada | 89119 | United States |
| Inspire Santa Fe Medical Group | Santa Fe | New Mexico | 87505 | United States |
| OnSite Clinical Solutions | Salisbury | North Carolina | 28144 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Medical Care/CCT | Elizabethton | Tennessee | 37643 | United States |
| PanAmerican Clinical Research, LLC | Brownsville | Texas | 78520 | United States |
| Quality Research Inc. | San Antonio | Texas | 78209 | United States |
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
| Paratus Clinical Research Western Sydney | Blacktown | New South Wales | 2148 | Australia |
| Emeritus Research Sydney | Botany | New South Wales | 2019 | Australia |
| Paratus Clinical Research Central Coast | Kanwal | New South Wales | 2259 | Australia |
| A R Houston Medical Pty Ltd | Kippa-Ring | Queensland | 4021 | Australia |
| Emeritus Research Melbourne | Camberwell | Victoria | 3124 | Australia |
| Austin Health - Repatriation Hospital | Heidelberg | Victoria | 3084 | Australia |
| New Hospitals | Tbilisi | 0114 | Georgia |
| Evex Hospitals Caraps Medline | Tbilisi | 0159 | Georgia |
| Aversi Clini | Tbilisi | 0160 | Georgia |
| The First Medical Center | Tbilisi | 0180 | Georgia |
| Academician Vakhtang Bochorishvili Clinic | Tbilisi | 0186 | Georgia |
| Innova | Tbilisi | 0186 | Georgia |
| Clinical Research Center (CRC) | Guatemala City | 01010 | Guatemala |
| Clínica Médica Especializada en Medicina Interna y Reumatología (CREER) | Guatemala City | 01010 | Guatemala |
| Clínica Médica Especializada en Medicina Interna y Reumatología | Guatemala City | 01010 | Guatemala |
| Clínica Médica Especializada en Medicina Interna | Guatemala City | 01010 | Guatemala |
| Buddhist Dalin Tzu Chi General Hospital | Chiayi City | 62247 | Taiwan |
| Chang Gung Memorial Hospital CGMH | Kaohsiung City | 833 | Taiwan |
| Chung Shan Medical Univ. Hospital | Taichung | 402367 | Taiwan |
| Cheng-Shin General Hospital | Taipei | 112401 | Taiwan |
| Chang Gung Memorial Hospital LinKou | Taoyuan | 333423 | Taiwan |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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