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AST-120 Used to Treat Mild Hepatic Encephalopathy (ASTUTE)

Primary Purpose

Mild Hepatic Encephalopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AST-120
Sponsored by
Ocera Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Hepatic Encephalopathy focused on measuring Hepatic encephalopathy, Mild hepatic encephalopathy, HE, MHE, Cognitive impairment, Cognitive dysfunction, Liver Disease, Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Arizona
  • UCSF - Fresno Community Regional Medical Center
  • UCSD Medical Center
  • Scripps Clinic
  • UCSD Medical Center
  • California Pacific Medical Center
  • Yale University School of Medicine
  • Washington Hospital Center
  • University of Florida College of Medicine
  • Mayo Clinic Jacksonville
  • University of Miami, Division of Hepatology / Center for Liver Disease
  • Northwestern University, Feinberg School of Medicine
  • Rush University Medical Center
  • VA Medical Center / University of Iowa Hospital and Clinics
  • University of Louisville
  • Delta Research Partners, LLC
  • Tulane University Health Sciences Center
  • Massachusetts General Hospital
  • Beth Israel Deaconnes Medical Center, Harvard Medical School
  • University of Massachusetts Memorial Medical Center
  • Dartmouth Hitchcock Medical Center
  • Weill Medical College of Cornell
  • University of Rochester Medical Center
  • New York Medical College
  • University of Cincinatti
  • Case Western Reserve / MetroHealth Medical Center
  • Cleveland Clinic Foundation
  • Temple University Hospital
  • Albert Einstein Medical Center, Division of Hepatology
  • University of Pittsburgh Medical Center
  • Medical University of Southern Carolina
  • Baylor University Medical Center
  • UT Southwestern Medical Center
  • Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine
  • Permian Research Foundation
  • University of Utah Health Sciences Center
  • McGuire DVAMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

AST-120 (6g)

Placebo A

AST-120 (12g)

Placebo B

Arm Description

2 grams TID

2 grams TID

4 grams TID

4 grams TID

Outcomes

Primary Outcome Measures

Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2009
Last Updated
June 2, 2014
Sponsor
Ocera Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00867698
Brief Title
AST-120 Used to Treat Mild Hepatic Encephalopathy
Acronym
ASTUTE
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ocera Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Hepatic Encephalopathy
Keywords
Hepatic encephalopathy, Mild hepatic encephalopathy, HE, MHE, Cognitive impairment, Cognitive dysfunction, Liver Disease, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AST-120 (6g)
Arm Type
Experimental
Arm Description
2 grams TID
Arm Title
Placebo A
Arm Type
Placebo Comparator
Arm Description
2 grams TID
Arm Title
AST-120 (12g)
Arm Type
Experimental
Arm Description
4 grams TID
Arm Title
Placebo B
Arm Type
Placebo Comparator
Arm Description
4 grams TID
Intervention Type
Drug
Intervention Name(s)
AST-120
Other Intervention Name(s)
Spherical carbon adsorbent
Intervention Description
AST-120
Primary Outcome Measure Information:
Title
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed cirrhosis of any cause Abnormal RBANS global summary score Grade 0 or 1 hepatic encephalopathy by West-Haven Scale MELD score < or = 25 Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control Exclusion Criteria: Previous participation in any trial involving AST-120 History of TIPS or surgically created portocaval shunt Treatment for overt HE within the past 3 months Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days Active alcohol abuse Psychosis or organic brain syndromes due to alcohol or other causes Use of interferon and sedating or cognition-altering drugs Undergoing chemotherapy or radiotherapy for the treatment of cancer Active GI bleeding within the past 3 months Presence of an active infection Presence of signs and symptoms of severe dehydration Other major physical or major psychiatric illness within the past 6 months Pregnant, breast feeding, or planning to become pregnant during the study Using hormonal contraception as the only method of birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Bornstein, MD
Organizational Affiliation
Ocera Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
UCSF - Fresno Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami, Division of Hepatology / Center for Liver Disease
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
VA Medical Center / University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Delta Research Partners, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconnes Medical Center, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Weill Medical College of Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of Cincinatti
City
Cincinatti
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve / MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Albert Einstein Medical Center, Division of Hepatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of Southern Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9151
Country
United States
Facility Name
Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Permian Research Foundation
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

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AST-120 Used to Treat Mild Hepatic Encephalopathy

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