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Completed

NCT Number: NCT00867698

AST-120 Used to Treat 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.

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Key information

Conditions

Mild Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

AST-120

Drug

AST-120

Other names: Spherical carbon adsorbent

Primary outcomes

  1. Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Ocera Therapeutics

Industry

Registry information

Official study 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

Acronym: ASTUTE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2009
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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