SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 31, 2002

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Hepatitis C
Interventions
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.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00590564 - SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study | Biotech Hunter | Biotech Hunter