Status:
COMPLETED
Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis
Lead Sponsor:
Tarek Hassanein
Collaborating Sponsors:
Shanghai Sundise Traditional Chinese Medicine Co., Ltd.
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Current treatment of chronic liver disease relies upon removing the primary insult to the liver (e.g., alcohol) or treating the underlying viral infection (HBV, HCV, etc.). However, in the case of hep...
Eligibility Criteria
Inclusion
- Main
- Male or female 18-70 years of age.
- 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.
- Failure to achieve sustained Virologic response (SVR) with previous Interferon based therapy or subjects who refuse Interferon based therapy or are intolerant to Interferon.
- 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.
- Main
Exclusion
- 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).
- Liver histology consistent with any other co-existing cause of chronic liver disease (apart from fatty liver).
- Subjects who have been treated for HCV infection within 6 months before Screening.
- Subjects who have been on any experimental protocol or therapy within 28 days before Screening.
- Known HIV infection.
- Chronic hepatitis B infection
- Uncontrolled diabetes.
- Unstable or uncontrolled thyroid disease
- Uncontrolled seizures disorder.
- History of malignant cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma.
- Alcohol and/or drug abuse within the past year.
- Pregnant or lactating women or women who plan to become pregnant during the study.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00854087
Start Date
August 1 2010
End Date
August 1 2013
Last Update
May 19 2021
Active Locations (8)
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1
SCTI Research Foundation
Coronado, California, United States, 92118
2
VA Palo Alto HCS
Palo Alto, California, United States, 94304
3
Huntington Medical Research Institutes
Pasadena, California, United States, 91105
4
UC Davis Health System
Sacramento, California, United States, 95817