Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tarek Hassanein
With
Shanghai Sundise Traditional Chinese Medicine Co., Ltd.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female 18-70 years of age.
2. Chronic hepatitis C infection based on documented history of a positive serum anti-HCV antibody test and/or detectable levels of HCV RNA ≥ 50 IU/mL.
3. Failure to achieve sustained Virologic response (SVR) with previous Interferon based therapy or subjects who refuse Interferon based therapy or are intolerant to Interferon.
4. All subjects enrolling in the study and all fertile or potentially fertile sexual partners of subjects must be using two reliable forms of effective contraception during the study unless a study participant/partner is surgically sterile or postmenopausal.
You may not be if
1. Subjects with any history of decompensated liver disease, including but not restricted to portal hypertension as manifested by gastroesophageal varices, variceal bleeding, ascites, or encephalopathy or a hepatic mass lesion suspicious for hepatocellular carcinoma (HCC).
2. Liver histology consistent with any other co-existing cause of chronic liver disease (apart from fatty liver).
3. Subjects who have been treated for HCV infection within 6 months before Screening.
4. Subjects who have been on any experimental protocol or therapy within 28 days before Screening.
5. Known HIV infection.
6. Chronic hepatitis B infection
7. Uncontrolled diabetes.
8. Unstable or uncontrolled thyroid disease
9. Uncontrolled seizures disorder.
10. History of malignant cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma.
11. Alcohol and/or drug abuse within the past year.
12. Pregnant or lactating women or women who plan to become pregnant during the study.
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