Hepatic EncephalopathyPhase 2AST015NCT00558038
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
A Phase 2 study testing AST-120 and lactulose in people with Hepatic Encephalopathy, run by Ocera Therapeutics at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- AST-120 and lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2007to Jun 2009
- 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
- Patients with End Stage Liver Disease secondary to any cause (patients who have undergone portosystemic shunting (TIPS) procedure > 3 months prior to randomization can be included)
- Lactulose naïve patients or patients currently on an established dose of lactulose
- MELD score ≤ 15 (MELD score up to 20 is allowable if it has remained stable for at least 3 months)
- Meet the criteria for Stage 1-2 hepatic encephalopathy according to the Westhaven Scale
- Patients must have discontinued rifaximin or other oral antibiotics for at least 48 hours prior to randomization
- Able and willing to comply with all protocol procedures for the planned duration of the study
Show all 10Show fewer
- Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
- Have a person (spouse, relative, or friend) willing to accompany the patient to the study visits (patients in this condition are not recommended to drive a vehicle)
- Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
- Note: Patients already on lactulose and randomized to AST-120 will stop taking lactulose on the day they begin taking AST-120.
Who cannot join
- Patients whose condition necessitates continuous administration of antibiotics (e.g. rifaximin, neomycin, metronidazole)
- Patients undergoing chemotherapy for treatment of cancer (patients with hepatocellular carcinoma being treated by methods other than chemotherapy may be enrolled)
- Patients who require continued treatment with narcotics or sedatives
- Patients who have active GI bleeding
- Patients who have an active infection
- Patients who have signs and symptoms of severe dehydration
Show all 9Show fewer
- Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling
- Unable to attend all visits required by the protocol
- Female patients must be EXCLUDED if they are pregnant, breast feeding, planning to become pregnant during the study or using hormonal contraception as their only method of birth control
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
University of Alabama
Birmingham, Alabama, 35294
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Medical Center
Dallas, Texas, 75246
Metropolitan Research
Fairfax, Virginia, 22031
Baylor University Medical Center
Houston, Texas, 77030
St. Luke's Advanced Liver Therapies / St. Luke's Texas Liver Coalition - Baylor College of Medicine
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Weill Medical College of Cornell
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
McGuire VA Medical Center
Richmond, Virginia, 23249
Scripps Clinic
San Diego, California, 92037
Veterans Medical Center San Diego
San Diego, California, 92161
Washington Hospital Center - MedStar Research Institute
Washington D.C., District of Columbia, 20010
University of Massachusetts Medical School
Worchester, Massachusetts, 01655
About this study
Official title: Comparison of Different Treatment Regimens in Patients With Stage 1-2 Type C Hepatic Encephalopathy: AST-120 vs Lactulose
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.
Read the detailed description
This is a multi-center, open-label, four week trial comparing AST-120 to lactulose in patients with mild (Stage 1-2) hepatic encephalopathy.
Patients will be randomized into two groups:
- Lactulose
- AST-120
Patients meeting the inclusion criteria will take either AST-120 or lactulose for 4 weeks (28 days). AST-120 will be distributed in 2 gram sachets to be taken four times daily. Lactulose will be taken in the same formulation, at the same dose and frequency as previously prescribed for the individual patient.
Lactulose naïve patients who are randomized to lactulose will receive an initial dose of 30cc twice a day. The dose should be titrated at the discretion of the investigator until the patient is experiencing 2-3 soft stools per day.
Patients randomized to AST-120 will receive 2 grams four times a day for the duration of the study. Titration of AST-120 will NOT be allowed.
Patients will be evaluated throughout the study for efficacy and safety. A follow-up visit will be scheduled 1 week after the end of the 4 week treatment period.
- Conditions
- Hepatic Encephalopathy
- Being tested
- AST-120, lactulose
- Keywords
- Hepatic, Encephalopathy, Liver, Liver Disease, Liver Failure, Lactulose, AST-120
- Medical subject headings
- Hepatic Encephalopathy, Brain Diseases, Liver Diseases, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-120Drug
AST-120
lactuloseDrug
Also called Chronulac, Constilac, Constulose, Duphalac, Evalose
lactulose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: lactulose |
| 2 | Experimental | Not described Receives: Drug: AST-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Westhaven Scale
Measured: 4 weeks
Secondary outcomes (7)
Efficacy: Change in Hepatic Encephalopathy Scoring Algorithm (HESA)
Measured: 4 weeks
Efficacy: Reduction of venous ammonia levels
Measured: 4 weeks
Efficacy: Serum bile acids and amino acid profile
Measured: 4 weeks
Efficacy: Reduction in itching (visual analog scale)
Measured: 4 weeks
Efficacy: Presence or absence of asterixis
Measured: 4 weeks
Safety: Clinical laboratory tests
Measured: 4 weeks
Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate, body temperature)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Pockros, MD, Principal investigator, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558038
- Sponsor's protocol ID
- AST015
- Acronym
- AST015
- Status last verified
- May 2014
- First submitted
- 9 Nov 2007
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Treatment Regimens in Patients With Stage 1-2 Type C Hepatic Encephalopathy: AST-120 vs Lactulose
- ClinicalTrials.gov ID
- NCT00558038
- Acronym / sponsor ID
- AST015 / AST015
- Conditions
- Hepatic Encephalopathy
- Keywords
- Hepatic, Encephalopathy, Liver, Liver Disease, Liver Failure, Lactulose, AST-120
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ocera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Nov 2007 (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 evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.
Detailed description
This is a multi-center, open-label, four week trial comparing AST-120 to lactulose in patients with mild (Stage 1-2) hepatic encephalopathy.
Patients will be randomized into two groups:
- Lactulose
- AST-120
Patients meeting the inclusion criteria will take either AST-120 or lactulose for 4 weeks (28 days). AST-120 will be distributed in 2 gram sachets to be taken four times daily. Lactulose will be taken in the same formulation, at the same dose and frequency as previously prescribed for the individual patient.
Lactulose naïve patients who are randomized to lactulose will receive an initial dose of 30cc twice a day. The dose should be titrated at the discretion of the investigator until the patient is experiencing 2-3 soft stools per day.
Patients randomized to AST-120 will receive 2 grams four times a day for the duration of the study. Titration of AST-120 will NOT be allowed.
Patients will be evaluated throughout the study for efficacy and safety. A follow-up visit will be scheduled 1 week after the end of the 4 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: lactulose |
| 2 | Experimental | Drug: AST-120 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with End Stage Liver Disease secondary to any cause (patients who have undergone portosystemic shunting (TIPS) procedure > 3 months prior to randomization can be included)
- Lactulose naïve patients or patients currently on an established dose of lactulose
- MELD score ≤ 15 (MELD score up to 20 is allowable if it has remained stable for at least 3 months)
- Meet the criteria for Stage 1-2 hepatic encephalopathy according to the Westhaven Scale
- Patients must have discontinued rifaximin or other oral antibiotics for at least 48 hours prior to randomization
Key exclusion criteria (9 listed)
- Patients whose condition necessitates continuous administration of antibiotics (e.g. rifaximin, neomycin, metronidazole)
- Patients undergoing chemotherapy for treatment of cancer (patients with hepatocellular carcinoma being treated by methods other than chemotherapy may be enrolled)
- Patients who require continued treatment with narcotics or sedatives
- Patients who have active GI bleeding
- Patients who have an active infection
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-120AST-120 | Drug | 2 |
| lactuloseAlso: Chronulac, Constilac, Constulose, Duphalac, Evaloselactulose | Drug | 1 |
Primary outcome
Change in Westhaven Scale
Time frame: 4 weeks
7 secondary outcomes
Efficacy: Change in Hepatic Encephalopathy Scoring Algorithm (HESA)
Time frame: 4 weeks
Efficacy: Reduction of venous ammonia levels
Time frame: 4 weeks
Efficacy: Serum bile acids and amino acid profile
Time frame: 4 weeks
Efficacy: Reduction in itching (visual analog scale)
Time frame: 4 weeks
Efficacy: Presence or absence of asterixis
Time frame: 4 weeks
Safety: Clinical laboratory tests
Time frame: 4 weeks
Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate, body temperature)
Time frame: 4 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 30 May 2014.
Related trials for Hepatic Encephalopathy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Liver Cirrhosis, Hepatic Encephalopathy (HE)
Recruiting
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Cirrhosis, Portal Hypertension
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
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.
Paul Pockros, MD principal investigator
Scripps Clinic
17 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 and lactulose in people with Hepatic Encephalopathy, run by Ocera Therapeutics at 17 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 10 inclusion and 9 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 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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?
Change in Westhaven Scale (time frame: 4 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 30 May 2014.