Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
Primary Purpose
Liver Cirrhosis Due to Hepatitis B Virus
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir + Placebo
Entecavir + Fuzheng Huayu Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis Due to Hepatitis B Virus
Eligibility Criteria
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.
Sites / Locations
- Guangxi Ruikang HospitalRecruiting
- The Fifth Hospital of ShijiazhuangRecruiting
- The Fifth People's Hospital of AnyangRecruiting
- Jingmen No.1 People's HospitalRecruiting
- Hubei Hospital of TCMRecruiting
- Tongji HospitalRecruiting
- The First Affiliated Hospital of Hunan University of TCMRecruiting
- Huai'an No. 4 People's HospitalRecruiting
- The Fifth People's Hospital of SuzhouRecruiting
- The Ninth Hospital of NanchangRecruiting
- Ningxia People's HospitalRecruiting
- Affiliated Hospital of Shandong Univercity of TCMRecruiting
- Wenzhou Central HospitalRecruiting
- Beijing Ditan Hospital Capital Medical UniversityRecruiting
- Beijing Youan Hospital Capital Medical UniversityRecruiting
- China-Japan Friendship HospitalRecruiting
- ShuGuang HospitalRecruiting
- Ruijin HospitalRecruiting
- Shanghai Zhongshan HospitalRecruiting
- Shenzhen Third People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Entecavir + Placebo
Entecavir + Fuzheng Huayu Tablet
Arm Description
Tablet with Entrcavir+ Tablet with starch
Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Outcomes
Primary Outcome Measures
Degree of liver fibrosis
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02241590
First Posted
September 12, 2014
Last Updated
October 12, 2018
Sponsor
ShuGuang Hospital
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT02241590
Brief Title
Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
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 Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital
Collaborators
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
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis Due to Hepatitis B Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Entecavir + Placebo
Arm Type
Placebo Comparator
Arm Description
Tablet with Entrcavir+ Tablet with starch
Arm Title
Entecavir + Fuzheng Huayu Tablet
Arm Type
Experimental
Arm Description
Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Intervention Type
Drug
Intervention Name(s)
Entecavir + Placebo
Intervention Description
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Entecavir + Fuzheng Huayu Tablet
Intervention Description
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
Primary Outcome Measure Information:
Title
Degree of liver fibrosis
Description
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.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenghai Liu, PhD
Phone
8621-20256521
Email
chenghailiu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenghai Liu, PhD
Organizational Affiliation
ShuGuang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Guangxi Ruikang Hospital
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
The Fifth Hospital of Shijiazhuang
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Fifth People's Hospital of Anyang
City
Anyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Jingmen No.1 People's Hospital
City
Jingmen
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Hospital of TCM
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Hunan University of TCM
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Huai'an No. 4 People's Hospital
City
Huai'an
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
The Fifth People's Hospital of Suzhou
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
The Ninth Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Ningxia People's Hospital
City
Yinchuan
State/Province
Ningxia
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Shandong Univercity of TCM
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Wenzhou Central Hospital
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Youan Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
ShuGuang Hospital
City
Shanghai
ZIP/Postal Code
201203
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Zhao, PhD
Phone
8621-20256409
Email
kilorair@sina.com
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen Third People's Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
32572776
Citation
Li ZX, Zhao ZM, Liu P, Zheng QS, Liu CH. Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet () and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial. Chin J Integr Med. 2021 Jul;27(7):509-513. doi: 10.1007/s11655-020-3257-6. Epub 2020 Jun 22.
Results Reference
derived
Learn more about this trial
Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
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