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

This study has been completed.
Sponsor:
Collaborator:
Shanghai Sundise Traditional Chinese Medicine Co., Ltd.
Information provided by (Responsible Party):
Tarek Hassanein, SCTI Research Foundation
ClinicalTrials.gov Identifier:
NCT00854087
First received: February 26, 2009
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: Fuzheng Huayu
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by SCTI Research Foundation:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline to Week 60 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.

  • 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. [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]

    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.



Enrollment: 118
Study Start Date: August 2010
Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fuzheng Huayu
Pill with Fuzheng Huayu
Drug: Fuzheng Huayu
The subjects will be taking 2 tablets three times a day for 48 weeks.
Other Names:
  • Gan Ping
  • 319 Recipe
  • FZHY
Placebo Comparator: Placebo
Pill without Fuzheng Huayu (sugar pill)
Drug: Placebo
The subjects will be taking 2 tablets three times a day for 48 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854087

Locations
United States, California
SCTI Research Foundation
Coronado, California, United States, 92118
VA Palo Alto HCS
Palo Alto, California, United States, 94304
Huntington Medical Research Institutes
Pasadena, California, United States, 91105
UC Davis Health System
Sacramento, California, United States, 95817
Southern California Liver Centers
San Clemente, California, United States, 92673
United States, Florida
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
United States, Texas
St. Luke's Advanced Liver Therapies
Houston, Texas, United States, 77030
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Tarek Hassanein
Shanghai Sundise Traditional Chinese Medicine Co., Ltd.
Investigators
Principal Investigator: Tarek Hassanein, MD SCTI Research Foundation
  More Information

No publications provided

Responsible Party: Tarek Hassanein, Medical Director, SCTI Research Foundation
ClinicalTrials.gov Identifier: NCT00854087     History of Changes
Other Study ID Numbers: Fuzheng Huayu S-USIIT-01 Study
Study First Received: February 26, 2009
Results First Received: May 19, 2014
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SCTI Research Foundation:
Hepatitis C Virus
HCV
Herbal treatment
Herbs
San Diego
Non responder
Relapser
Treatment failure
Antifibrotic
Anti-fibrotic
Fibrosis
Failure of previous Interferon based therapy
Refuse Interferon based therapy
Intolerance to Interferon
Male or female 18-70 years of age

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 28, 2014