CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Sho-saiko-todrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00590564
NCT00590564Phase 2Completed
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SHO-SAIKO-TO for Patients With Chronic Hepatitis C Who Are Intolerant to or Have Contraindication to Interferon-Based Therapy: A Phase II Study

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 10, 2008·Updated Jan 15, 2016

In Brief

A Phase 2 clinical trial evaluating Sho-saiko-to for Hepatitis C. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2008
Enrollment StartOct 1, 2002
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 18.5 years ago

Interventions

Sho-saiko-todrug

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.