SHO-SAIKO-TO for Patients With Chronic Hepatitis C Who Are Intolerant to or Have Contraindication to Interferon-Based Therapy: A Phase II Study
Chronic hepatitis C affects nearly three million Americans. Of these, 15% will develop liver
cirrhosis and approximately 5% will progress to hepatocellular carcinoma. Treatment for
chronic hepatitis C is limited to interferon-based therapy. Many patients decline or cannot
tolerate interferon because of its serious side effects. Sho-saiko-to, an Asian herbal
medicine consisting of seven botanicals, has demonstrated anti-fibrotic affect by inhibition
of lipid peroxidation in hepatocytes and stellate cells in an animal study. It has also been
demonstrated to prevent progression of cirrhosis to hepatocellular carcinoma in human
trials. This study is a single arm, single center trial of Sho-saiko-to in patients with
chronic active hepatitis from hepatitis C infection who cannot tolerate or who have specific
contraindications to interferon therapy. Patients will receive 52 weeks therapy with
Sho-saiko-to. Outcome will be assessed by comparing pre- and posttreatment liver biopsies.
Patients will be said to respond if they have an improvement of two points or greater on a
standard measure of liver histology. If five or more of 25 evaluable patients respond,
Sho-saiko-to will be deemed worthy of further testing.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the effects of Sho-saiko-to on hepatic injury in patients with chronic hepatitis C who are intolerant or have a specific contraindication to interferon-based therapy.
Gary Deng, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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