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The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AST-120 (6g) | Experimental | 2 grams TID |
|
| Placebo A | Placebo Comparator | 2 grams TID |
|
| AST-120 (12g) | Experimental | 4 grams TID |
|
| Placebo B | Placebo Comparator | 4 grams TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AST-120 | Drug | AST-120 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Bornstein, MD | Ocera Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Arizona |
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| Phoenix |
| Arizona |
| 85054 |
| United States |
| UCSF - Fresno Community Regional Medical Center | Fresno | California | 93721 | United States |
| UCSD Medical Center | La Jolla | California | 92161 | United States |
| Scripps Clinic | San Diego | California | 92037 | United States |
| UCSD Medical Center | San Diego | California | 92101 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| University of Miami, Division of Hepatology / Center for Liver Disease | Miami | Florida | 33136 | United States |
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| VA Medical Center / University of Iowa Hospital and Clinics | Iowa City | Iowa | 52246 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Delta Research Partners, LLC | Monroe | Louisiana | 71201 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconnes Medical Center, Harvard Medical School | Boston | Massachusetts | 02215 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Weill Medical College of Cornell | New York | New York | 10021 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| University of Cincinatti | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve / MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Albert Einstein Medical Center, Division of Hepatology | Philadelphia | Pennsylvania | 19141 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of Southern Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-9151 | United States |
| Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Permian Research Foundation | Odessa | Texas | 79761 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| McGuire DVAMC | Richmond | Virginia | 23249 | United States |
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D060825 | Cognitive Dysfunction |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| 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 |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C040896 | AST 120 |
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