Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis

Chronic Hepatitis C Infection Clinical Trial

Official title:

A Phase II, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854087
• Other study ID #: Fuzheng Huayu S-USIIT-01 Study
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: April 2021
• Source: SCTI Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 hepatitis C, a significant number of individuals will not clear the virus with current approved standard antiviral therapy, leaving them no options to manage their hepatic fibrosis, which can progress to cirrhosis and ultimately hepatocellular carcinoma (HCC). Fuzheng Huayu has been used in numerous studies in China and has been found to have a satisfactory prophylaxis effect on the chronic liver injury and formed liver fibrosis in rats and humans. In addition, it enhances the degradation of liver fibrosis and protects hepatocytes from injury and death, manifesting as decreasing of ALT and AST, and enhancement of albumin level. In addition, preliminary studies indicate that the Fuzheng Huayu has a good safety and tolerability profile with promising efficacy. The number of patients failing Interferon based therapy (i.e. not achieving SVR) is increasing. There are no approved standard of care treatment options for this population nor for patients who are intolerant or unwilling to receive Interferon; thus they are at higher risk for the progression of fibrosis. Moreover, there are no approved therapies to treat hepatic fibrosis, but basic research is exploring the pathophysiological mechanisms. Fuzheng Huayu is easy to administer, with a good safety and efficacy profile against fibrosis. Therefore, the investigators propose to further study the safety and efficacy profile of Fuzheng Huayu in a randomized, placebo-controlled, double blind study in Chronic Hepatitis C patients with hepatic fibrosis who have failed prior anti-HCV therapy or are intolerant or refuse Interferon based therapy. The primary objective of this study is to establish the safety and efficacy of Fuzheng Huayu treatment in chronic hepatitis C subjects who have failed prior anti-HCV therapy or cannot receive or refused Interferon based therapy in improving liver fibrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Main Inclusion Criteria:

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.

Main Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Fuzheng Huayu
The subjects will be taking 2 tablets three times a day for 48 weeks.
• Placebo
The subjects will be taking 2 tablets three times a day for 48 weeks.

Locations

Country	Name	City	State
United States	SCTI Research Foundation	Coronado	California
United States	St. Luke's Advanced Liver Therapies	Houston	Texas
United States	VA Palo Alto HCS	Palo Alto	California
United States	Huntington Medical Research Institutes	Pasadena	California
United States	Advanced Medical Research Center	Port Orange	Florida
United States	UC Davis Health System	Sacramento	California
United States	University of Utah HSC	Salt Lake City	Utah
United States	Southern California Liver Centers	San Clemente	California

Sponsors (2)

Lead Sponsor	Collaborator
Tarek Hassanein	Shanghai Sundise Traditional Chinese Medicine Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.	Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.	Baseline to Week 60
Primary	Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.	Efficacy of Fuzheng Huayu treatment was assessed through the change in liver fibrosis stage from the assessment before (pre) and after (post) study drug. The liver fibrosis staging system used was the Ishak scale. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.; "Fibrosis improved" was defined as a lower post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 3 or lower.; "Fibrosis did not change" was defined as having the same Ishak score before and after study drug assessments e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 4.; "Fibrosis worsened" was defined as a higher post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 5 or higher.	Baseline to Week 48