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A Phase II Study of Sho-saiko-to in Patients with Chronic Hepatitis C Who Cannot Use Interferon
[Protocol 02-073]
- Full Title :
- SHO-SAIKO-TO FOR PATIENTS WITH CHRONIC HEPATITIS C WHO ARE INTOLERANT TO OR HAVE CONTRAINDICATION TO INTERFERON-BASED THERAPY: A PHASE II STUDY
- Purpose :
Researchers at Memorial Sloan-Kettering Cancer Center are evaluating a Japanese/Chinese herbal medicine called Sho-saiko-to to see if it can help patients with chronic hepatitis C. Chronic hepatitis C may cause inflammation in the liver, which can lead to scarring called fibrosis. In some patients, chronic hepatitis C may result in cirrhosis (severe scarring of the liver), liver failure, and liver cancer.
Standard treatment for chronic hepatitis C includes a drug called interferon, given with or without another drug called ribavirin. Because interferon has a number of side effects, many patients are unable to take it. There are no other proven treatments for chronic hepatitis C.
Sho-saiko-to is an herbal medicine that has been used for many years in Asia to treat liver disease. There is emerging scientific evidence that Sho-saiko-to may benefit patients with hepatitis. The purpose of this phase II study is to determine whether Sho-saiko-to is effective in treating the liver inflammation and injury caused by chronic hepatitis C in patients who cannot take interferon.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of chronic hepatitis C.
- Patients who have received interferon and ribavirin less than 6 months ago will need to wait for a period of time before enrolling in the study. The doctor will make the specific recommendations.
- Patients who also have HIV or hepatitis B infection may not participate. Patients who drink more than 40 grams of alcohol daily also may not participate.
- Patients must be at least 18 years old.
For more information and to see if you are eligible for this study, please contact James Lozada, Research Study Assistant, 646-888-0811.
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