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

NCT00590564 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-01-15

Study results available
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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.

Conditions

  • Hepatitis C

Interventions

DRUG

Sho-saiko-to

All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks unless occurrence of unacceptable adverse events or patient withdrawal. Patients will be seen for clinical follow-up at three month intervals: at 3, 6, 9, and 12 months, and assessed for compliance and asked about side effects and pulmonary symptoms. At each clinic visit, a comprehensive metabolic profile will be performed. At the 6-month clinic visit, a CBC will be performed. At the 12-month clinic visit, quantitative HCV-RNA by PCR will be obtained (Viromed Labs, Inc., 6101 Blue Circle Drive, Minneapolis, MN 5534). Within 4 weeks after the 12-month clinic visit (after 52 weeks of SST therapy), the second liver biopsy will be scheduled and performed.

Sponsors & Collaborators

Principal Investigators

  • Gary Deng, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590564 on ClinicalTrials.gov