Mild Hepatic EncephalopathyPhase 2ASTUTENCT00867698
AST-120 Used to Treat Mild Hepatic Encephalopathy
A Phase 2 study testing AST-120 in people with Mild Hepatic Encephalopathy, run by Ocera Therapeutics at 38 sites in United States.
Trial summary
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mild Hepatic Encephalopathy
- What is being tested?
- AST-120
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 38 sitesUnited States
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconnes Medical Center, Harvard Medical School
Boston, Massachusetts, 02215
Medical University of Southern Carolina
Charleston, South Carolina, 29425
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinatti
Cincinnati, Ohio, 45267
Case Western Reserve / MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Medical Center
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390-9151
UCSF - Fresno Community Regional Medical Center
Fresno, California, 93721
University of Florida College of Medicine
Gainesville, Florida, 32610
Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine
Houston, Texas, 77030
VA Medical Center / University of Iowa Hospital and Clinics
Iowa City, Iowa, 52246
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
UCSD Medical Center
La Jolla, California, 92161
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Louisville
Louisville, Kentucky, 40202
University of Miami, Division of Hepatology / Center for Liver Disease
Miami, Florida, 33136
Delta Research Partners, LLC
Monroe, Louisiana, 71201
Yale University School of Medicine
New Haven, Connecticut, 06520
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Weill Medical College of Cornell
New York, New York, 10021
Permian Research Foundation
Odessa, Texas, 79761
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Albert Einstein Medical Center, Division of Hepatology
Philadelphia, Pennsylvania, 19141
Mayo Clinic Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
McGuire DVAMC
Richmond, Virginia, 23249
University of Rochester Medical Center
Rochester, New York, 14642
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Scripps Clinic
San Diego, California, 92037
UCSD Medical Center
San Diego, California, 92101
California Pacific Medical Center
San Francisco, California, 94115
New York Medical College
Valhalla, New York, 10595
Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
- Conditions
- Mild Hepatic Encephalopathy
- Being tested
- AST-120
- Keywords
- Hepatic encephalopathy, Mild hepatic encephalopathy, HE, MHE, Cognitive impairment, Cognitive dysfunction, Liver Disease, Cirrhosis
- Medical subject headings
- Hepatic Encephalopathy, Cognitive Dysfunction, Liver Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-120Drug
Also called Spherical carbon adsorbent
AST-120
| Study group | Role | What they receive |
|---|---|---|
| AST-120 (6g) | Experimental | 2 grams TID Receives: Drug: AST-120 |
| Placebo A | Placebo comparator | 2 grams TID Receives: Drug: AST-120 |
| AST-120 (12g) | Experimental | 4 grams TID Receives: Drug: AST-120 |
| Placebo B | Placebo comparator | 4 grams TID Receives: Drug: AST-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeff Bornstein, MD, Study director, Ocera Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867698
- Sponsor's protocol ID
- AST-MHE201
- Acronym
- ASTUTE
- Status last verified
- Jun 2014
- First submitted
- 20 Mar 2009
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00867698
- Acronym / sponsor ID
- ASTUTE / AST-MHE201
- Conditions
- Mild Hepatic Encephalopathy
- Keywords
- Hepatic encephalopathy, Mild hepatic encephalopathy, HE, MHE, Cognitive impairment, Cognitive dysfunction, Liver Disease, Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ocera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AST-120 (6g) | Experimental | Drug: AST-1202 grams TID |
| Placebo A | Placebo comparator | Drug: AST-1202 grams TID |
| AST-120 (12g) | Experimental | Drug: AST-1204 grams TID |
| Placebo B | Placebo comparator | Drug: AST-1204 grams TID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-120Also: Spherical carbon adsorbentAST-120 | Drug | AST-120 (12g), AST-120 (6g), Placebo A, Placebo B |
Primary outcome
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Bornstein, MD study director
Ocera Therapeutics, Inc.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AST-120 in people with Mild Hepatic Encephalopathy, run by Ocera Therapeutics at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.