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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00558038
Other study ID # AST015
Secondary ID
Status Completed
Phase Phase 2
First received November 9, 2007
Last updated May 27, 2014
Start date September 2007
Est. completion date June 2009

Study information

Verified date May 2014
Source Ocera Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AST-120
AST-120
lactulose
lactulose

Locations

Country Name City State
United States Digestive Healthcare of Georgia Atlanta Georgia
United States University of Alabama Birmingham Alabama
United States University of Chicago Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States Baylor University Medical Center Dallas Texas
United States Metropolitan Research Fairfax Virginia
United States Baylor University Medical Center Houston Texas
United States St. Luke's Advanced Liver Therapies / St. Luke's Texas Liver Coalition - Baylor College of Medicine Houston Texas
United States Cedars Sinai Medical Center Los Angeles California
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Mount Sinai School of Medicine New York New York
United States Weill Medical College of Cornell New York New York
United States McGuire VA Medical Center Richmond Virginia
United States Scripps Clinic San Diego California
United States Veterans Medical Center San Diego San Diego California
United States Washington Hospital Center - MedStar Research Institute Washington District of Columbia
United States University of Massachusetts Medical School Worchester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Ocera Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Westhaven Scale 4 weeks No
Secondary Efficacy: Change in Hepatic Encephalopathy Scoring Algorithm (HESA) 4 weeks No
Secondary Efficacy: Reduction of venous ammonia levels 4 weeks No
Secondary Efficacy: Serum bile acids and amino acid profile 4 weeks No
Secondary Efficacy: Reduction in itching (visual analog scale) 4 weeks No
Secondary Efficacy: Presence or absence of asterixis 4 weeks No
Secondary Safety: Clinical laboratory tests 4 weeks No
Secondary Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate, body temperature) 4 weeks No
See also
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