A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Treatments: Glycerol

Criteria

Inclusion Criteria:

• Subjects aged 18 and over

• Clinical diagnosis of cirrhosis of any cause

• Potential to benefit from HE treatment

• History of greater than or equal to 2 documented episodes of WH Grade 2 or more HE within the past 6 months, at least one of which occurred within the preceding 3 months

• No change in other HE-specific medications within 1 week before randomization

• Able to give informed consent and comply with study activities

• Availability of at least one designated family member or caregiver who is capable of and willing to assume responsibility for facilitating subject compliance with study procedures

• All females of childbearing age and all sexually active males must agree to use an acceptable method of contraception throughout the study.

Exclusion Criteria:

• Use of any investigational drug within 30 days

• Use of prohibited medications

• Uncontrolled infection

• Active GI bleeding or a history of GI bleeding requiring blood transfusion (> 2 units) within 3 months

• Transjugular intrahepatic portosystemic shunt (TIPS) placement or revision within the past 90 days

• Recreational drug use or alcohol consumption for subjects with a history of alcohol or drug abuse within 6 months

• Lactating and/or pregnant females

• Active malignancy

• Clinically significant bowel disease, including obstruction, inflammatory bowel disease, or malabsorption

• Expected to undergo transplantation within 6 months

• Model for end-stage liver disease (MELD) score of > 25