Mild Hepatic Encephalopathy Clinical Trial
— ASTUTEOfficial title:
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of AST-120 (Spherical Carbon Adsorbent) for 8 Weeks in the Treatment of Mild Hepatic Encephalopathy
| Verified date | June 2014 |
| Source | Ocera Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | June 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 1. Confirmed cirrhosis of any cause 2. Abnormal RBANS global summary score 3. Grade 0 or 1 hepatic encephalopathy by West-Haven Scale 4. MELD score < or = 25 5. Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control Exclusion Criteria: 1. Previous participation in any trial involving AST-120 2. History of TIPS or surgically created portocaval shunt 3. Treatment for overt HE within the past 3 months 4. Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days 5. Active alcohol abuse 6. Psychosis or organic brain syndromes due to alcohol or other causes 7. Use of interferon and sedating or cognition-altering drugs 8. Undergoing chemotherapy or radiotherapy for the treatment of cancer 9. Active GI bleeding within the past 3 months 10. Presence of an active infection 11. Presence of signs and symptoms of severe dehydration 12. Other major physical or major psychiatric illness within the past 6 months 13. Pregnant, breast feeding, or planning to become pregnant during the study 14. Using hormonal contraception as the only method of birth control |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Beth Israel Deaconnes Medical Center, Harvard Medical School | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Medical University of Southern Carolina | Charleston | South Carolina |
| United States | Northwestern University, Feinberg School of Medicine | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Cincinatti | Cincinatti | Ohio |
| United States | Case Western Reserve / MetroHealth Medical Center | Cleveland | Ohio |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | UCSF - Fresno Community Regional Medical Center | Fresno | California |
| United States | University of Florida College of Medicine | Gainesville | Florida |
| United States | Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine | Houston | Texas |
| United States | VA Medical Center / University of Iowa Hospital and Clinics | Iowa City | Iowa |
| United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
| United States | UCSD Medical Center | La Jolla | California |
| United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | University of Louisville | Louisville | Kentucky |
| United States | University of Miami, Division of Hepatology / Center for Liver Disease | Miami | Florida |
| United States | Delta Research Partners, LLC | Monroe | Louisiana |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
| United States | Weill Medical College of Cornell | New York | New York |
| United States | Permian Research Foundation | Odessa | Texas |
| United States | Albert Einstein Medical Center, Division of Hepatology | Philadelphia | Pennsylvania |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Arizona | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | McGuire DVAMC | Richmond | Virginia |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
| United States | Scripps Clinic | San Diego | California |
| United States | UCSD Medical Center | San Diego | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | New York Medical College | Valhalla | New York |
| United States | Washington Hospital Center | Washington | District of Columbia |
| United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Ocera Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline. | 8 weeks | No |