Status:
COMPLETED
Trial of Hepaguard® in Adults With Nonalcoholic Steatohepatitis
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide. Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a progressive course and m...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. Patients with nonalcoholic steatohepatitis (NASH), a severe form of NAFLD characterized by ball...
Eligibility Criteria
Inclusion
- Age 18 years or above,
- Histologic NAFLD activity score 3,
- Written informed consent
Exclusion
- Positive hepatitis B surface antigen, or anti-hepatitis C virus antibody, or histologic features of an alternative liver disease,
- Alcohol consumption above 30g per week in men or 20g per week in women,
- Serum alanine aminotransferase above 10 times the upper limit of normal,
- Liver decompensation,
- Evidence of hepatocellular carcinoma currently or in the past 5 years,
- Type 1 diabetes or insulin treatment,
- Use of investigational drugs in the last 12 weeks,
- Terminal illness or cancer
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01210989
Start Date
May 1 2010
End Date
May 1 2012
Last Update
February 24 2014
Active Locations (1)
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1
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, China