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NCT00590564 · ClinicalTrials.gov registry record · Phase 2
SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT00590564: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00590564 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590564, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Sho-saiko-to
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2002-10 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT00590564 record still lists
NCT00590564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Sho-saiko-to is the first listed.
NCT00590564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00590564 about?
NCT00590564 is a clinical study titled "SHO-SAIKO-TO for Patients With Chronic Hepatitis C: 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...
What is the current status of trial NCT00590564?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2002-10. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00590564?
The interventions under investigation include: Sho-saiko-to (DRUG).
Who is sponsoring clinical trial NCT00590564?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590564's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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