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

Last updated: October 12, 2018
Sponsor: ShuGuang Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Hepatitis

Liver Disorders

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT02241590
SGHLC20140818001
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-fibrosisdrug was taken within 6 months.

  • Child-Pugh<7 (Stage A)

  • The patient or the patient's guardian agrees to participate the trial and sign theinformed Consent Form.

Exclusion

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 severenon-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronichepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis,primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxicinduced 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 celldisease, 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 marrowtransplantation and stem cell transplantation.

  • Immunocompromised patients: such as HIV infection or take immunosuppressor orglucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancerchemotherapy) and radioactive therapy.

  • Gestation or lactation period women and women who plan to get pregnant during thestudy 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 Design

Total Participants: 700
Study Start date:
September 01, 2014
Estimated Completion Date:
June 30, 2019

Connect with a study center

  • Guangxi Ruikang Hospital

    Nanning, Guangxi
    China

    Active - Recruiting

  • The Fifth Hospital of Shijiazhuang

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • The Fifth People's Hospital of Anyang

    Anyang, Henan
    China

    Active - Recruiting

  • Jingmen No.1 People's Hospital

    Jingmen, Hubei
    China

    Active - Recruiting

  • Hubei Hospital of TCM

    Wuhan, Hubei
    China

    Active - Recruiting

  • Tongji Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • The First Affiliated Hospital of Hunan University of TCM

    Changsha, Hunan
    China

    Active - Recruiting

  • Huai'an No. 4 People's Hospital

    Huai'an, Jiangsu
    China

    Active - Recruiting

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu
    China

    Active - Recruiting

  • The Ninth Hospital of Nanchang

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Ningxia People's Hospital

    Yinchuan, Ningxia
    China

    Active - Recruiting

  • Affiliated Hospital of Shandong Univercity of TCM

    Jinan, Shandong
    China

    Active - Recruiting

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang
    China

    Active - Recruiting

  • Beijing Ditan Hospital Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Beijing Youan Hospital Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • China-Japan Friendship Hospital

    Beijing,
    China

    Active - Recruiting

  • Ruijin Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Zhongshan Hospital

    Shanghai,
    China

    Active - Recruiting

  • ShuGuang Hospital

    Shanghai, 201203
    China

    Active - Recruiting

  • Shenzhen Third People's Hospital

    Shenzhen,
    China

    Active - Recruiting

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