Status:
WITHDRAWN
Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C
Lead Sponsor:
University of Virginia
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 curr...
Detailed Description
Persons infected with hepatitis C virus (HCV) suffer from multiple symptoms caused by both the disease and the current conventional treatment (peginterferon alfa and ribavirin) if they can tolerate th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00633230
Last Update
June 25 2015
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