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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 8
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fuzheng Huayu
Pill with Fuzheng Huayu
干预措施: Fuzheng Huayu (Drug)
Placebo
Pill without Fuzheng Huayu (sugar pill)
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: Baseline to Week 60
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.
时间窗: Baseline to Week 48
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.
次要结局
未报告次要终点
研究者
Tarek Hassanein
Medical Director
SCTI Research Foundation