Wednesday, November 6, 2013

Fuzheng Huayu (FZHY) Completed Phase II Clinical Trial for Treatment of Liver Fibrosis in Patients With Chronic Hepatitis C

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).

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