NCT02241616

Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: ShuGuang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis B Virus Related Cirrhosis

Interventions

Type	Name	Description
DRUG	Entecavir+Fuzheng Huayu+TCM Granule	The subjects will be taking 1 Entecavir tablet per day, 4 Fuzheng Huayu tablets three times a day and specific Traditional Chinese Medicine granule for 48 weeks.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2014-09-16
• Last updated: 2018-10-15

Locations

20 sites across 1 country: China