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
Intervention: Fuzheng Huayu; Placebo
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Male or female 18-70 years of age.

          2. Chronic hepatitis C infection based on documented history of a positive serum anti-HCV
             antibody test and/or detectable levels of HCV RNA ≥ 50 IU/mL.

          3. Failure to achieve sustained Virologic response (SVR) with previous Interferon based
             therapy or subjects who refuse Interferon based therapy or are intolerant to
             Interferon.

          4. All subjects enrolling in the study and all fertile or potentially fertile sexual
             partners of subjects must be using two reliable forms of effective contraception
             during the study unless a study participant/partner is surgically sterile or
             postmenopausal.

        Main Exclusion Criteria:

          1. Subjects with any history of decompensated liver disease, including but not restricted
             to portal hypertension as manifested by gastroesophageal varices, variceal bleeding,
             ascites, or encephalopathy or a hepatic mass lesion suspicious for hepatocellular
             carcinoma (HCC).

          2. Liver histology consistent with any other co-existing cause of chronic liver disease
             (apart from fatty liver).

          3. Subjects who have been treated for HCV infection within 6 months before Screening.

          4. Subjects who have been on any experimental protocol or therapy within 28 days before
             Screening.

          5. Known HIV infection.

          6. Chronic hepatitis B infection

          7. Uncontrolled diabetes.

          8. Unstable or uncontrolled thyroid disease

          9. Uncontrolled seizures disorder.

         10. History of malignant cancer within the last 5 years with the exception of localized
             basal or squamous cell carcinoma.

         11. Alcohol and/or drug abuse within the past year.

         12. Pregnant or lactating women or women who plan to become pregnant during the study.