Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Fibrosis
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Fuzheng Huayu; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The subjects will be taking 2 tablets three times a day for 48 weeks.; The subjects will be taking 2 tablets three times a day for 48 weeks.
Other intervention name(s): Gan Ping; 319 Recipe; FZHY
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C Virus; HCV; Herbal treatment; Herbs; San Diego; Non responder; Relapser; Treatment failure; Antifibrotic; Anti-fibrotic; Fibrosis; Failure of previous Interferon based therapy; Refuse Interferon based therapy; Intolerance to Interferon; Male or female 18-70 years of age