Hepatitis CPhase 2NCT00590564
SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study
A Phase 2 study testing Sho-saiko-to in people with Hepatitis C, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sho-saiko-to
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Hepatitis C
- Being tested
- Sho-saiko-to
- Keywords
- Hepatitis C, Sho-saiko-to, SST, Interferon Therapy
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sho-saiko-toDrug
Also called sst
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Drug: Sho-saiko-to |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2002
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Deng, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590564
- Sponsor's protocol ID
- 02-073
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2007
- Last updated
- 15 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00590564
- Acronym / sponsor ID
- 02-073
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Sho-saiko-to, SST, Interferon Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 15 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sho-saiko-toAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sho-saiko-toAlso: sstAll 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. | Drug | 1 |
Primary outcome
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.
Time frame: 52 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering web siteLink provided by the sponsor.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Deng, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sho-saiko-to in people with Hepatitis C, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.