Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy

NCT00558038 | Completed Phase 2

• 1 other identifier: AST015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Hepatic Encephalopathy

Keywords

Hepatic; Encephalopathy; Liver; Liver Disease; Liver Failure; Lactulose; AST-120

Outcome Measures

Primary Outcomes (1)

• Change in Westhaven Scale

  4 weeks

Secondary Outcomes (7)

• Efficacy: Change in Hepatic Encephalopathy Scoring Algorithm (HESA)

  4 weeks

• Efficacy: Reduction of venous ammonia levels

  4 weeks

• Efficacy: Serum bile acids and amino acid profile

  4 weeks

• Efficacy: Reduction in itching (visual analog scale)

  4 weeks

• Efficacy: Presence or absence of asterixis

  4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: lactulose

2

EXPERIMENTAL

Drug: AST-120

Interventions

AST-120 DRUG

AST-120

2

lactulose DRUG

lactulose

Also known as: Chronulac, Constilac, Constulose, Duphalac, Evalose

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocera Therapeutics: lead

Study Sites (17)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Scripps Clinic

San Diego, California, 92037, United States

Location

Veterans Medical Center San Diego

San Diego, California, 92161, United States

Location

Washington Hospital Center - MedStar Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Digestive Healthcare of Georgia

Atlanta, Georgia, 30309, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Massachusetts Medical School

Worchester, Massachusetts, 01655, United States

Location

Weill Medical College of Cornell

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Baylor University Medical Center

Houston, Texas, 77030, United States

Location

St. Luke's Advanced Liver Therapies / St. Luke's Texas Liver Coalition - Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Brain Diseases; Liver Diseases; Liver Failure

Interventions

AST 120; Lactulose

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Digestive System Diseases; Brain Diseases, Metabolic; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Paul Pockros, MD

  Scripps Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 14, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

US (17)