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Sponsor is stopping the study to focus company resources on other development programs.
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This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXA1665 53.8 g per day | Experimental | AXA1665 administered orally TID |
|
| Matching placebo | Placebo Comparator | Placebo administered orally TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXA1665 | Drug | AXA1665 administered TID with food |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES) | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to and frequency of recurrent overt hepatic encephalopathy | Baseline to week 24 | |
| Impact on physical function assessed by Liver Frailty Index (a composite measure of hand grip strength, balance and ability to stand up from a chair) | Baseline to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Duarte-Rojo, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco (UCSF) | San Francisco | California | 94143 | United States | ||
| OMEGA Research Consultants |
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| Label | URL |
|---|---|
| EMMPOWER Phase 2 Clinical Trial Homepage | View source |
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| Placebo |
| Drug |
Matching placebo administered TID with food |
|
| Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) | Baseline to week 24 |
| DeBary |
| Florida |
| 32713 |
| United States |
| UF Hepatology Research at CTRB | Gainesville | Florida | 32610 | United States |
| Homestead Associates in Research | Miami | Florida | 33032 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| New York University (NYU) School of Medicine | New York | New York | 10016 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Cumberland Research Associates | Fayetteville | North Carolina | 28304 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Optimed Research | Edinburg | Texas | 78359 | United States |
| Baylor Scott & White Research Institute | Fort Worth | Texas | 75246 | United States |
| Advanced Liver Therapies at St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22903 | United States |
| Bon Secours Liver Institute | Newport News | Virginia | 23602 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23114 | United States |
| McGuire Research Institute, Inc., McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| LMC Diabetes & Endocrinology Ltd. - London | London | Ontario | N6A 2C2 | Canada |
| The Ottawa Hospital | Ottawa | Canada |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | Hungary |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Azienda sanitaria universitaria Friuli Centrale (ASU FC) | Udine | 33100 | Italy |
| KO - MED Centra Kliniczne Lublin II | Lublin | Poland |
| ID Clinic | Mysłowice | Poland |
| SONOMED Sp. z o.o. | Szczecin | Poland |
| Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka | Warsaw | Poland |
| Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p. | Wroclaw | Poland |
| Corporacio Sanitaria Parc Tauli - Hospital de Sabadell | Barcelona | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
| The Royal Infirmary of Edinburgh | Edinburgh | United Kingdom |
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| D058625 | End Stage Liver Disease |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
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