Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to (1) determine the effects of the herbal formula Sho-saiko-to (SST) compared to placebo in treating hepatitis C virus (HCV) in persons who have not responded to the current conventional therapy (peginterferon alfa and ribavirin) or who have relapsed or in those for whom conventional therapy is contraindicated; (2) determine the influence that SST will have on participant reports of depression/sadness, fear and uncertainty related to the HCV disease progression, and renewal of hope in these individuals; and (3) collect preliminary data needed to examine feasibility, patient acceptance, and any potential limitations of the study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia

Criteria

Inclusion Criteria:

• Diagnosed with hepatitis C virus (HCV) genotype 1 with detectable HCV RNA >2000IU/mL at baseline assessment.

• Have relapsed after the standard care peginterferon alfa and ribavirin, or did not respond, or standard care peginterferon alfa and ribavirin contraindicated.

• Age 18 to 65 years

• Gender: male or female

• If female of childbearing potential (uterus has not been removed), willingness to use an approved form of birth control with male sexual partners through entire study and for 3 months after study completion

• Chest x-ray negative for pulmonary disease within 6 months of enrollment

Exclusion Criteria:

• Age < 18 or > 65 years.

• Currently on peginterferon alfa and ribavirin therapy, or have been on this therapy within the past 6 months.

• Currently taking monoamine oxidase inhibitors (MAOIs) for depression or have a serious mental illness.

• Diagnosed with cardiac disease, including severe heart failure, arrhythmia; significant kidney disease; asthma or other obstructive or restrictive pulmonary disease, interstitial pneumonitis and/or hypoxemia, leading to difficulty breathing or shortness of breath; immune-mediated disease (e.g., rheumatoid arthritis, vasculitis).

• Pulmonary function resulting in Forced Expiratory Volume (FEV1) at least 80% predicted.

• Confirmed diagnosis of TB.

• Infected with HIV, hepatitis A, B, D, E, or other viral blood infection (e.g., EBV, CMV)

• Taking anticoagulant therapy or have had anticoagulants within 30 days of enrollment

• Have taken antiviral medications within past 30 days

• Laboratory tests resulting in:

• platelet count ≤100,000/mm3

• serum bilirubin >1.5 g/dL

• Prothrombin Time-International Normalized Ratio (INR) >1.5

• albumin <3.4 g/dL

• hemoglobin <13 g/dL in men, <12 g/dL in women

• Absolute Neutrophil Count (ANC) <1.5 k/dL

• serum creatinine >1.5 mg/dL

• alanine transaminase (ALT) > 10 x baseline

• Hypertension (SBP > 140 or DBP >90)

• Hypokalemia (K < 3.5)

• Liver biopsy results that reveal stage 4 fibrosis (cirrhosis)

• Cirrhosis or at risk for developing hepatocellular carcinoma as evidenced by an elevated AFP test at screening.

• Undergone transplant of any kind and/or taking corticosteroids or other immunosuppressive therapy (or have taken immunosuppressive therapy within the previous 6 months)

• Consuming alcohol.

• Hypersensitivity to any of the 7 components of SST.

• Taking over-the counter products that could potentially interact with the components of SST.

• Have participated in another investigational drug study within the past 60 days.

• Taking anthraquinone drugs or herbs containing anthraquinone

• In a methadone maintenance program.

• Using recreational drugs.

• Pregnant, breastfeeding, or unwillingness to use an approved form of birth control for women of childbearing potential.

• Unable to understand the consent process or study-related questions due to language barriers, cognitive impairment, or other reasons.

• Weigh more than 275 pounds, which could complicate liver biopsy procedures.