Clinical trial NCT00867698: AST-120 Used to Treat Mild Hepatic Encephalopathy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Hepatic Encephalopathy
Keywords: Hepatic encephalopathy
Mild hepatic encephalopathy
HE
MHE
Cognitive impairment
Cognitive dysfunction
Liver Disease
Cirrhosis
Lead sponsor: Ocera Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-03-24
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.


Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Fresno
country: United States
facility: UCSF - Fresno Community Regional Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
city: San Diego
country: United States
facility: Scripps Clinic
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami, Division of Hepatology / Center for Liver Disease
state: Florida
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: VA Medical Center / University of Iowa Hospital and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconnes Medical Center, Harvard Medical School
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Weill Medical College of Cornell
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Cincinatti
country: United States
facility: University of Cincinatti
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve / MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center, Division of Hepatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of Southern Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine
state: Texas
city: Odessa
country: United States
facility: Permian Research Foundation
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
Study officials:
affiliation: Ocera Therapeutics, Inc.
name: Jeff Bornstein, MD
role: STUDY_DIRECTOR
References: