Here is the information about the New York trial (along with the request from Dr. Wen for me to get this information out to you).

Hi Ralph,

Thank you very much for agreeing to help spread the word about our New York trial on Hepatitis C. As we have discussed on the phone, our clinical trial at Sloan-Kettering is still enrolling patients. We need help to make the awareness of the trial to patients in New York area and I believe the thousands of hep C patients who are subscribing to your e-newsletter at http://www.hepatitis-central.com would be excited to hear this opportunity. I have also copied this email to Dr. Gary Deng, the Primary Investigator of the trial at Sloan, for his information. The following information about the trial is copied from Sloan-Kettering website at http://www.mskcc.org/mskcc/html/2270.cfm?IRBNO=02-073, from which you can see all eligibility criteria and the contact information.

Sincerely,

Dr. Wen

Phase II Study of Sho-saiko-to in Patients with Chronic Hepatitis C Who Cannot Use Interferon

[Protocol 02-073]

Full 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

Purpose:

Researchers at Memorial Sloan-Kettering Cancer Center are evaluating a Japanese/Chinese herbal medicine called Sho-saiko-to to see if it can help patients with chronic hepatitis C. Chronic hepatitis C may cause inflammation in the liver, which can lead to scarring called fibrosis. In some patients, chronic hepatitis C may result in cirrhosis (severe scarring of the liver), liver failure, and liver cancer.

Standard treatment for chronic hepatitis C includes a drug called interferon, given with or without another drug called ribavirin. Because interferon has a number of side effects, many patients are unable to take it. There are no other proven treatments for chronic hepatitis C.

Sho-saiko-to is an herbal medicine that has been used for many years in Asia to treat liver disease. There is emerging scientific evidence that Sho-saiko-to may benefit patients with hepatitis. The purpose of this phase II study is to determine whether Sho-saiko-to is effective in treating the liver inflammation and injury caused by chronic hepatitis C in patients who cannot take interferon.

Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:

· Patients who have received interferon and ribavirin less than 6 months ago will need to wait for a period of time before enrolling in the study. The doctor will make the specific recommendations.
· Patients must be at least 18 years old.
For more information and to see if you are eligible for this study, please contact to Cheryl Co at 212-639-8610.

Here is the information on the San Diego study:

Hi Ralph,

As you can see below, the UCSD group has approved you to proceed with the contact information for enrolling new patients at their site for the trial and the website link for detail. Please use the two clinical trial sites for your communication materials to introduce the need from each site (New York and San Diego) for patients to enroll.

Best regards,

Dr. Wen

Hi Fatma,

We have a good connection to Hepatitis Central. They are able to broadcast any hepatitis C related news to a large body of patients (http://www.hepatitis-central.com/mt/). Currently they are preparing a news piece to include information about the enrollment for the SST study in New York. If you like we can include the UCSD trial information you have posted at the webpage http://health.ucsd.edu/ntrials/031532.htm to help you enrolling patients.

Please confirm with me if we can proceed with this initiative.

Regards,

Dr. Wen

Hi Dr. Wen,

The matter was discussed with Dr. Hassanein and we can confirm that you can proceed with linking the website. Also, please note that Lita Petcharaporn will be the coordinator on the study. Her contact information is below:

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

Thank you,

Fatma

Fatma Barakat
Clinical Research Coordinator
UCSD Liver Center
200 West Arbor Drive
San Diego, CA 92103-8707
Phone: (619) 543-5459
Fax: (619) 543-6392
fbarakat@ucsd.edu

CHSD Clinical Research project
Project Number: 031532
Scientific Title:

Safety and Tolerability of Sho-saiko-to (SST) in Patients with Compensated Cirrhosis Due to Chronic HCV Infection, A Double blinded Phase II Trial

Principal Investigator (ie., Lead Researcher):

Tarek Hassanein, MD

Description:

The purpose of this study is to evaluate the safety and tolerability of an investigational drug called Sho-saiko-to (SST) as well as find out more about preventing a type of liver cancer called Hepatocellular Carcinoma (HCC) from occuring in patients who have Chronic Hepatitis C infection and cirrhosis. SST is a Chinese herbal drug mixture of seven different herbs: Bupleurum Root, Pinellia, Ginger, Scutellaria, Jujube, Ginseng and Licorice.
This is an outpatient study.

Eligibility criteria:
Gender: Both males and females are eligible to participate. Minimum age: 18. Hepatitis C Virus and Cirrhosis
Exclusions (conditions which would prevent a volunteer from participating in this study):

Please contact Fatma Barakat

Location:

UCSD Medical Center, Hillcrest

Compensation:

Study drug will be provided at no cost.

For further information about this study, please contact:

Fatma Barakat
Phone: (619) 543-5459