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A Multi-Center Study to Assess the Efficacy and Safety of Traditional Chinese Medicine Combined With Entecavir for Patients With Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV
Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of Liver cirrhosis in China. The effective inhibition of HBV can partially regress or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, however some patients keep existence or development although HBV DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required the anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve the reversion of refractory liver fibrosis in liver cirrhosis due to HBV. The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in liver cirrhosis due to HBV.
Details
| Lead sponsor | ShuGuang Hospital |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 350 |
| Start date | 2014-09 |
| Completion | 2019-06 |
Conditions
- Hepatitis B Virus Related Cirrhosis
Interventions
- Entecavir+Fuzheng Huayu+TCM Granule
Primary outcomes
- Degree of liver fibrosis — 48 weeks
The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression.
Countries
China