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

October 12, 2018 updated by: Liu Chenghai, ShuGuang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
      • Beijing, China
        • Recruiting
        • Beijing Ditan Hospital Capital Medical University
      • Beijing, China
        • Recruiting
        • Beijing Youan Hospital Capital Medical University
      • Shanghai, China
        • Recruiting
        • Shanghai Zhongshan Hospital
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital
      • Shanghai, China, 201203
        • Recruiting
        • ShuGuang Hospital
        • Contact:
      • Shenzhen, China
        • Recruiting
        • Shenzhen Third People's Hospital
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Ruikang Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fifth Hospital of Shijiazhuang
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • The Fifth People's Hospital of Anyang
    • Hubei
      • Jingmen, Hubei, China
        • Recruiting
        • Jingmen NO.1 People's Hospital
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Hospital of TCM
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The first affiliated hospital of Hunan University of TCM
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Recruiting
        • Huai'an No. 4 People's Hospital
      • Suzhou, Jiangsu, China
        • Recruiting
        • The Fifth People's Hospital of Suzhou
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Ninth Hospital of Nanchang
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • Ningxia People's Hospital
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Affiliated Hospital of Shandong Univercity of TCM
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Recruiting
        • Wenzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShuGuang Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGHLC20140818001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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