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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cirrhosis, Hepatic Encephalopathy

In brief

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).

Key facts

Study ID

NCT00999167

Run by

Amgen

People needed

189

Starts

2009-12-01

Expected to finish

2012-04-01

Last updated by the study team

2024-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center, Division of Gastroenterology and Hepatology — Palo Alto, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Miami / Center for Liver Diseases — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Tulane University Health Science Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Henry Ford Hospital / Department of Gastroenterology — Detroit, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Concorde Medical Group PLLC — New York, New York, United States
• NYU Medical Center — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center / Center for Liver Disease and Transplantation — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• New York Medical College / Westchester Medical Center — Valhalla, New York, United States
• University of Cincinnati / Division of Digestive Diseases — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Digestive Disease Center at Vanderbilt — Nashville, Tennessee, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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