Trial record 1 of 2 for:
AST-015
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy (AST015)
This study has been completed.
Sponsor:
Ocera Therapeutics
Information provided by (Responsible Party):
Ocera Therapeutics
ClinicalTrials.gov Identifier:
NCT00558038
First received: November 9, 2007
Last updated: September 28, 2011
Last verified: March 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatic Encephalopathy |
Drug: AST-120 Drug: lactulose |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Different Treatment Regimens in Patients With Stage 1-2 Type C Hepatic Encephalopathy: AST-120 vs Lactulose |
Resource links provided by NLM:
Further study details as provided by Ocera Therapeutics:
Primary Outcome Measures:
- Change in Westhaven Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy: Change in Hepatic Encephalopathy Scoring Algorithm (HESA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Efficacy: Reduction of venous ammonia levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Efficacy: Serum bile acids and amino acid profile [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Efficacy: Reduction in itching (visual analog scale) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Efficacy: Presence or absence of asterixis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Safety: Clinical laboratory tests [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate, body temperature) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: lactulose
lactulose
Other Name: Chronulac, Constilac, Constulose, Duphalac, Evalose
|
| Experimental: 2 |
Drug: AST-120
AST-120
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558038
Locations
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Cedars Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Scripps Clinic | |
| San Diego, California, United States, 92037 | |
| Veterans Medical Center San Diego | |
| San Diego, California, United States, 92161 | |
| United States, District of Columbia | |
| Washington Hospital Center - MedStar Research Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Georgia | |
| Digestive Healthcare of Georgia | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| University of Massachusetts Medical School | |
| Worchester, Massachusetts, United States, 01655 | |
| United States, New York | |
| Weill Medical College of Cornell | |
| New York, New York, United States, 10021 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| St. Luke's Advanced Liver Therapies / St. Luke's Texas Liver Coalition - Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Baylor University Medical Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Metropolitan Research | |
| Fairfax, Virginia, United States, 22031 | |
| McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
Sponsors and Collaborators
Ocera Therapeutics
Investigators
| Principal Investigator: | Paul Pockros, MD | Scripps Clinic |
More Information
No publications provided
| Responsible Party: | Ocera Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00558038 History of Changes |
| Other Study ID Numbers: | AST015 |
| Study First Received: | November 9, 2007 |
| Last Updated: | September 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ocera Therapeutics:
|
Hepatic Encephalopathy Liver Liver Disease |
Liver Failure Lactulose AST-120 |
Additional relevant MeSH terms:
|
Hepatic Encephalopathy Brain Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolic Diseases Confusion |
Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Poisoning Substance-Related Disorders Lactulose Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013