A Phase 2 interventional study of Sho-saiko-to in Hepatitis C, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-15.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 42 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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Exclusion Criteria:
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.
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.
Also known as: sst
To Determine the Effects of Sho-saiko-to on Hepatic Injury in Patients With Chronic Hepatitis C Who Are Intolerant or Have a Specific Contraindication to Interferon-based Therapy.
Response is determined by improvement of 2 points or greater as per Knodell's histology activity index (HAI) scores in paired comparisons of pre and post liver biopsy
Time frame: 52 weeks
| Milestone | All Patients |
|---|---|
| Started | 42 |
| Completed | 24 |
| Not completed | 18 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Patient found to be ineligible | 1 |
| Withdrew: Patient non-compliance | 6 |
Response is determined by improvement of 2 points or greater as per Knodell's histology activity index (HAI) scores in paired comparisons of pre and post liver biopsy
| participants | All Patients |
|---|---|
| Responders | 5 |
| Non-responders | 19 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | — | 3/24 (12.5%) | 14/24 (58.3%) |
| Event | All Patients |
|---|---|
| Conduction abnormalityCardiac disorders | 1/24 |
| Cellulitis (skin)Skin and subcutaneous tissue disorders | 1/24 |
| PneumoniaReproductive system and breast disorders | 1/24 |
| Event | All Patients |
|---|---|
| Alanine Aminotransferase (ALT)Blood and lymphatic system disorders | 11/24 |
| Aspartate Aminotransferase (AST)Blood and lymphatic system disorders | 6/24 |
| HyperglycemiaMetabolism and nutrition disorders | 4/24 |
| NeutrophilsBlood and lymphatic system disorders | 3/24 |
| Abdominal pain/crampingGastrointestinal disorders | 2/24 |
| BilirubinHepatobiliary disorders | 2/24 |
| HypoalbuminemiaMetabolism and nutrition disorders | 2/24 |
| Age, Categorical(Participants) | All Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 40 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | All Patients |
|---|---|
| Female | 13 |
| Male | 29 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center