Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir

Sponsor

ShuGuang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02241590

Collaborator

Shanghai Zhongshan Hospital (Other), Guangxi Ruikang Hospital (Other), Hubei Hospital of Traditional Chinese Medicine (Other), The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine (Other), Huai'an No. 4 People's Hospital (Other), Ruijin Hospital (Other), Shenzhen Third People's Hospital (Other), Beijing Ditan Hospital (Other), Beijing YouAn Hospital (Other), China-Japan Friendship Hospital (Other), Tongji Hospital (Other), Wenzhou Central Hospital (Other), Jingmen No.1 People's Hospital (Other), Shandong University of Traditional Chinese Medicine (Other), The Ninth Hospital of Nanchang (Other), The People's Hospital of Ningxia (Other), Fifth Hospital of Shijiazhuang City (Other), The Fifth People's Hospital of Suzhou (Other), The Fifth People's Hospital of Anyang (Other)

700

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 :

Sep 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

More than 6 months history of serum positive HBsAg
Positive HBV-DNA
Age 18-60
Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-virus or anti-fibrosis drug was taken within 6 months.
Child-Pugh<7 (Stage A)
The patient or the patient's guardian agrees to participate the trial and sign the informed Consent Form.

Exclusion Criteria:

Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
Decompensated liver cirrhosis
HCC
Liver histology conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced liver injury, parasitic infections, alcoholic liver disease.
Have psychiatric history or uncontrollable epilepsy patient.
Uncontrollable diabetic patient
History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle cell disease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
Severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrow transplantation and stem cell transplantation.
Immunocompromised patients: such as HIV infection or take immunosuppressor or glucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3 months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancer chemotherapy) and radioactive therapy.
Gestation or lactation period women and women who plan to get pregnant during the study period.
Patient who are allergy to the experimental drug.
Using history of anti-viral or anti-fibrosis drug within 6 months.
Patients who are participating other trials.
Other situation where PI thinks the patient should be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangxi Ruikang Hospital	Nanning	Guangxi	China
2	The Fifth Hospital of Shijiazhuang	Shijiazhuang	Hebei	China
3	The Fifth People's Hospital of Anyang	Anyang	Henan	China
4	Jingmen No.1 People's Hospital	Jingmen	Hubei	China
5	Hubei Hospital of TCM	Wuhan	Hubei	China
6	Tongji Hospital	Wuhan	Hubei	China
7	The First Affiliated Hospital of Hunan University of TCM	Changsha	Hunan	China
8	Huai'an No. 4 People's Hospital	Huai'an	Jiangsu	China
9	The Fifth People's Hospital of Suzhou	Suzhou	Jiangsu	China
10	The Ninth Hospital of Nanchang	Nanchang	Jiangxi	China
11	Ningxia People's Hospital	Yinchuan	Ningxia	China
12	Affiliated Hospital of Shandong Univercity of TCM	Jinan	Shandong	China
13	Wenzhou Central Hospital	Wenzhou	Zhejiang	China
14	Beijing Ditan Hospital Capital Medical University	Beijing		China
15	Beijing Youan Hospital Capital Medical University	Beijing		China
16	China-Japan Friendship Hospital	Beijing		China
17	ShuGuang Hospital	Shanghai		China	201203
18	Ruijin Hospital	Shanghai		China
19	Shanghai Zhongshan Hospital	Shanghai		China
20	Shenzhen Third People's Hospital	Shenzhen		China

Sponsors and Collaborators

ShuGuang Hospital
Shanghai Zhongshan Hospital
Guangxi Ruikang Hospital
Hubei Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Huai'an No. 4 People's Hospital
Ruijin Hospital
Shenzhen Third People's Hospital
Beijing Ditan Hospital
Beijing YouAn Hospital
China-Japan Friendship Hospital
Tongji Hospital
Wenzhou Central Hospital
Jingmen No.1 People's Hospital
Shandong University of Traditional Chinese Medicine
The Ninth Hospital of Nanchang
The People's Hospital of Ningxia
Fifth Hospital of Shijiazhuang City
The Fifth People's Hospital of Suzhou
The Fifth People's Hospital of Anyang