Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
Current treatment of chronic liver disease relies upon removing the primary insult to the
liver (e.g., alcohol) or treating the underlying viral infection (HBV, HCV, etc.). However,
in the case of hepatitis C, a significant number of individuals will not clear the virus with
current approved standard antiviral therapy, leaving them no options to manage their hepatic
fibrosis, which can progress to cirrhosis and ultimately hepatocellular carcinoma (HCC).
Fuzheng Huayu has been used in numerous studies in China and has been found to have a
satisfactory prophylaxis effect on the chronic liver injury and formed liver fibrosis in rats
and humans. In addition, it enhances the degradation of liver fibrosis and protects
hepatocytes from injury and death, manifesting as decreasing of ALT and AST, and enhancement
of albumin level. In addition, preliminary studies indicate that the Fuzheng Huayu has a good
safety and tolerability profile with promising efficacy.
The number of patients failing Interferon based therapy (i.e. not achieving SVR) is
increasing. There are no approved standard of care treatment options for this population nor
for patients who are intolerant or unwilling to receive Interferon; thus they are at higher
risk for the progression of fibrosis. Moreover, there are no approved therapies to treat
hepatic fibrosis, but basic research is exploring the pathophysiological mechanisms. Fuzheng
Huayu is easy to administer, with a good safety and efficacy profile against fibrosis.
Therefore, the investigators propose to further study the safety and efficacy profile of
Fuzheng Huayu in a randomized, placebo-controlled, double blind study in Chronic Hepatitis C
patients with hepatic fibrosis who have failed prior anti-HCV therapy or are intolerant or
refuse Interferon based therapy.
The primary objective of this study is to establish the safety and efficacy of Fuzheng Huayu
treatment in chronic hepatitis C subjects who have failed prior anti-HCV therapy or cannot
receive or refused Interferon based therapy in improving liver fibrosis.
Phase:
Phase 2
Details
Lead Sponsor:
Tarek Hassanein
Collaborator:
Shanghai Sundise Traditional Chinese Medicine Co., Ltd.