Trial of Hepaguard® in Adults With Nonalcoholic Steatohepatitis

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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 may result in liver cirrhosis and liver cancer. However, there is yet proven treatment for this disorder. In cell line and animal studies, we have shown that Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation. Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the efficacy in NASH has not been confirmed in humans.

This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy. Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be further analyzed.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

• Age 18 years or above,

• Histologic NAFLD activity score 3,

• Written informed consent

Exclusion Criteria:

• 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