SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study

Status Completed

Clinical Trial Summary

Researchers want to see whether Sho-saiko-to (SST) can help in patients with chronic hepatitis C. Chronic hepatitis C may cause swelling within the liver and this can lead to scar tissue. In some patients, severe scarring of the liver, liver failure and liver cancer can occur. Standard treatment for chronic hepatitis C is a drug called interferon with or without another drug called ribavirin. There are a number of side effects that some patients are unable to take. Other patients may have an initial response, but then the virus and the inflammation come back.

Sho-saiko-to is an herbal medicine that has been used for many years in Asia to treat liver disease. The purpose of the study is to evaluate whether Sho-saiko-to may improve liver swelling and injury caused by chronic hepatitis C.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00590564
Study type	Interventional
Source	Memorial Sloan Kettering Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	October 2002
Completion date	February 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.