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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Different Treatment Regimens in Patients With Stage 1-2 Type C Hepatic Encephalopathy: AST-120 vs Lactulose

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.

Detailed Summary:

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.


Sponsor: Ocera Therapeutics

Current Primary Outcome: Change in Westhaven Scale [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Ocera Therapeutics

Dates:
Date Received: November 9, 2007
Date Started: September 2007
Date Completion:
Last Updated: May 27, 2014
Last Verified: May 2014