For Immediate Release

The Second Clinical Trial of Honso^® Sho-saiko-to (H09) on Patients with Liver Cirrhosis Caused by Hepatitis C Begins at USCD Liver Center

Oct. 1. 2004. Phoenix, Arizona. The stability and tolerability of the Japanese herbal formula Honso^® Sho-saiko-to (H09) will be tested in patients with cirrhosis of the liver due to chronic hepatits C virus (HCV) infections.  This will be a Phase II trial led by Tarek Hassanein, MD., Chief of Hepatology and Liver Transplant at UCSD Medical Center. The researchers at UCSD plan to determine the effects of Sho-saiko-to (H09) on patients with compensated cirrhosis.  The main focus of this study will be evaluating the anti-fibrotic effect and tolerability of Sho-saiko-to (H09) in the patients.

The UCSD trial is a double blinded and placebo controlled phase II study with an IND from the Food and Drug Administration (FDA).  There will be 40 patients taking part in this trial, 20 will receive Sho-saiko-to (H09) and the other 20 will receive placebo.  A medical history exam, lab data, lung function test, and chest x-ray will be evaluated during the screening visit. Patients will return for evaluation at weeks 1, 2, 4, 8, 12, 18, 24 after initial dosage is given and then every 8 weeks until week 48.  Quality of Life and other parameters will be evaluated throughout the trial.

Tarek Hassanein, MD., at UCSD sums up his thoughts on the trial by stating: “We’re excited about starting the study using Honso Sho-saiko-to in patients with liver cirrhosis, secondary to hepatitis C infection.  It is important to investigate complimentary medicine in a scientific base.  We look forward to evaluating Sho-saiko-to for its previously reported anti-fibrotic  and chemopreventive effects in cirrhotic patients.” 

Dan Wen, MD., the President of Honso USA, Inc. stated his opinions: “I am very excited about working together with Dr. Tarek Hassanein and the talented team of researchers at the UCSD Medical Center.  This is an important next step after our first trial at Sloan-Kettering Cancer Center, which is studying the effects of Sho-saiko-to (H09) on Hepatitis C patients.  We are now furthering our knowledge on the Sho-saiko-to (H09) formula by researching its effects on cirrhosis of the liver. Most importantly, we will be able to assess the safety issue of the herbal formula as the side effect of pneumonitis has been reported in Japan in the mid-90’s. So far, the patients that are on or finished the treatment at the Sloan-Kettering trial have not reported any side effects. This UCSD trial will address the safety issue among the cirrhosis patients, which will greatly help us to understand the herbal formula”.

For the patients who are interested in this trial, please contact UCSD Liver Center:

Lita Petcharaporn (Clinical Coordinator)
Phone: (619) 543-7218
Fax: (619) 543-6392
E-mail: lpetchar@ucsd.edu
 

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