Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
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|ClinicalTrials.gov Identifier: NCT02241590|
Recruitment Status : Unknown
Verified October 2018 by Liu Chenghai, ShuGuang Hospital.
Recruitment status was: Recruiting
First Posted : September 16, 2014
Last Update Posted : October 15, 2018
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 stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix is still required and hopefully improve the efficacy of anti-virals for liver fibrotic patients with HBV, 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 liver cirrhosis due to HBV.
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Due to Hepatitis B Virus||Drug: Entecavir + Placebo Drug: Entecavir + Fuzheng Huayu Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir in Liver Cirrhosis Patients Due to Hepatitis B Virus|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Placebo Comparator: Entecavir + Placebo
Tablet with Entrcavir+ Tablet with starch
Drug: Entecavir + Placebo
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
Experimental: Entecavir + Fuzheng Huayu Tablet
Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Drug: Entecavir + Fuzheng Huayu Tablet
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
- Degree of liver fibrosis [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241590
|Contact: Chenghai Liu, PhDemail@example.com|
|Study Director:||Chenghai Liu, PhD||ShuGuang Hospital|