Note: FZHY is also being used for Hepatitis B
SHANGHAI, CHINA--(Marketwired - Nov 5, 2013) - Shanghai Sundise Traditional Chinese Medicine Co. Ltd today
released its multi-center, double-blinded, placebo-controlled clinical
phase II trial results at a satellite symposium during the 2013 annual
meeting of American Association for Study of Liver Diseases (AASLD®).
The results indicate that in chronic hepatitis C patients with moderate
to severe fibrosis Fuzheng Huayu tablet (FZHY)
is safe, well tolerated and tended to stabilize and improve liver
fibrosis, making FZHY the first traditional Chinese medicine compound to
complete such clinical studies in the treatment of liver diseases.
Hepatitis C is the major cause of liver fibrosis, cirrhosis
and ultimately hepatocellular carcinoma (HCC) in the US. Newly approved
direct-acting antiviral agents may effectively clear hepatitis C virus.
However, the effects on underline liver fibrosis and cirrhosis remain to
be seen. Currently, there is no FDA approved anti-fibrosis therapy.
FZHY is a botanical compound approved in China for liver fibrosis caused
by hepatitis B virus infection. This is the first clinical phase II
trial of FZHY as botanical drug to assess the safety, tolerability, and
efficacy on fibrosis in HCV patients who have been previously failed the
anti-viral therapies, cannot receive or refused Interferon based
therapy. The trial was initiated in 2010 to evaluate FZHY with treatment
protocol for one year and pre- and post-treatment liver biopsy
assessments. The trial was funded by Shanghai Sundise Traditional
Chinese Medicine Co. Ltd, with eight US medical institutions and a team
of world-famous liver specialists working together. Detailed trial
information is available at www.clinicaltrials.gov (Identifier: NCT00854087).