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

June 2, 2014 updated by: Ocera Therapeutics

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Fresno, California, United States, 93721
        • UCSF - Fresno Community Regional Medical Center
      • La Jolla, California, United States, 92161
        • UCSD Medical Center
      • San Diego, California, United States, 92037
        • Scripps Clinic
      • San Diego, California, United States, 92101
        • UCSD Medical Center
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Miami, Florida, United States, 33136
        • University of Miami, Division of Hepatology / Center for Liver Disease
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • VA Medical Center / University of Iowa Hospital and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners, LLC
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconnes Medical Center, Harvard Medical School
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • Ohio
      • Cincinatti, Ohio, United States, 45267
        • University of Cincinatti
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44109
        • Case Western Reserve / MetroHealth Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center, Division of Hepatology
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of Southern Carolina
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75390-9151
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine
      • Odessa, Texas, United States, 79761
        • Permian Research Foundation
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AST-120 (6g)
2 grams TID
Drug: AST-120
AST-120
Other Names:
  • Spherical carbon adsorbent
Placebo Comparator: Placebo A
2 grams TID
Drug: AST-120
AST-120
Other Names:
  • Spherical carbon adsorbent
Experimental: AST-120 (12g)
4 grams TID
Drug: AST-120
AST-120
Other Names:
  • Spherical carbon adsorbent
Placebo Comparator: Placebo B
4 grams TID
Drug: AST-120
AST-120
Other Names:
  • Spherical carbon adsorbent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ocera Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jeff Bornstein, MD, Ocera Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AST-MHE201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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