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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Interferons

Criteria

Inclusion Criteria:

• Chronic hepatitis C diagnosis, with abnormal liver function tests, positive serology for Hepatitis C antibody, positive viremia as indicated by PCR techniques.

• Age 18 or over

• There must be no plans to use interferon in the following 12 months due to EITHER: a specific contraindication to interferon therapy, including but not limited to:history of depression, or other psychiatric disease, history of autoimmune disease,psoriasis, rheumatoid arthritis, history of renal dysfunction, thyroid abnormalities, seizure disorder, depressed blood cell counts, history of asthma OR patient discontinuation of interferon-based therapy prematurely due to intolerable side effects with sustained active viremia OR patient refusal to take interferon

• Patients must be able to understand and sign informed consent.

• Female participants must agree to practice approved methods of birth control (if applicable).

Exclusion Criteria:

• Coinfection with hepatitis B as defined by a positive Hepatitis B surface antigen (HBsAg) test.

• Coinfection with HIV

• Patients with alcohol intake >40g day

• Patients with recent myocardial infarction or heart failure.

• Concurrent use of Sho-saiko-to, or any of its constituent plants.

• Concurrent use of interferon containing products.

• Use of interferon-based treatment within the past 6 months.

• Women who are pregnant, nursing, or have the potential to becoming pregnant, unless utilizing birth control. A negative pregnancy test must be documented during the screening period for women of childbearing potential.

• History of malignancy, unless there is currently no evidence of disease and patient completed all surgery, radiotherapy and chemotherapy for that disease a minimum of two years previously

• Concurrent life-threatening illness, for which the prognosis is poor.

• Patients with diffusing capacity on pulmonary testing less than 50% of predicted will be excluded.

• Patients with diffusing capacity on pulmonary testing less than 70% of predicted AND total lung capacity less than 80% of predicted will be excluded.