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. (IRB # 009-050)

Short Title: Ocera

Study Description: This is a research study for individuals with cirrhosis who maybe experiencing some of the impairments of mild hepatic encephalopathy. The sponsor of this study, Ocera Therapeutics, Inc., is conducting this study to learn more about an investigational medicine called AST-120. This study is being done to learn more about the safety and effectiveness of AST-120 compared to placebo (material that does not contain any active medication), when it is given to treat mild hepatic encephalopathy. This study is randomized which means you will be assigned to receive AST-120 or placebo by chance, like flipping a coin. 

Some of the criteria for patients to qualify for the study include:

• Ages 18-70 inclusive;
• Confirmed cirrhosis of any cause;
• Companion (defined as a spouse, relative or friend familiar with the
  everyday activities of the subject) who is able and willing to attend
  two study visits (Visit 1 and Visit 3) and to participate in an
  interview at each visit.

The following are some of the criteria which will exclude patients from the study:

• Previous participation in any trial involving AST-120;
• History of TIPS (transvenous intrahepatic portocaval shunt) or
  surgically created portocaval shunt;
• Treatment for an episode of overt hepatic encephalopathy within the past 3  months.

Location:
Baylor University Medical Center                     
3500 Gaston Ave                                            
Dallas, TX 75246

Lead Principal Investigator: Rita Lepe, MD