Status:
COMPLETED
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
Lead Sponsor:
Amgen
Conditions:
Cirrhosis
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Part A: Open-label, dose-escalation lead-in to assess HPN-100 safety and PK Approximately 10 subjects with HE and cirrhosis classified as Child Pugh B or C will undergo a one-step dose escalation over...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00999167
Start Date
December 1 2009
End Date
April 1 2012
Last Update
July 10 2024
Active Locations (28)
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1
Stanford University Medical Center, Division of Gastroenterology and Hepatology
Palo Alto, California, United States, 94304
2
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
3
University of Miami / Center for Liver Diseases
Miami, Florida, United States, 33136
4
Tampa General Hospital
Tampa, Florida, United States, 33606