Treatment of Low-grade Cirrhotic Portal Hypertension Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir

Last updated: February 11, 2020
Sponsor: ShuGuang Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Liver Disorders

Diabetes And Hypertension

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT02945956
SGHLC20161023003
  • Ages 18-65
  • All Genders

Study Summary

Portal hypertension is a common pathology in chronic liver disease, particularly in liver cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The basic reason for portal hypertension in HBV is the largely deposition of hepatic extracellular matrixes which causes high pressure in liver vessels. One of the most common symptoms of cirrhotic portal hypertension is gastroesophageal varices.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 may have a great benefit. Therefore, antivirals therapy is also a basic treatment for low-grade cirrhotic portal hypertension. 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 relieve the pressure of liver vessels and decline incidence rate and bleeding rate of gastroesophageal varices.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • More than 6 months history of serum positive HBsAg

  • Abdominal ultrasonogram or CT scan or liver-biopsy specimen indicates liver cirrhosis

  • Age 18-65

  • Child-Pugh<7 (Stage A)

  • Without portal hypertension(Endoscopy indicates no signs of gastroesophageal varices.)

  • Low-grade of portal hypertension(Endoscopy indicates signs of gastroesophageal varicesthat is line shape without red wales or spots and less than 0.3cm of diameter.)

  • The patient or the patient's guardian agrees to participate the random controlledtrial and sign the Informed Consent Form.

Exclusion

Exclusion Criteria:

  • Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance

  • Decompensated cirrhosis、The Child-Pugh score≥7

  • Moderate grade of portal hypertension(Endoscopy indicates signs of gastroesophagealvarices that is line shape with red wales or spots and less than 0.3cm of diameter,orsnake large shape without red wales or spots and less than 1.0cm of diameter.)

  • Severe grade of portal hypertension(Endoscopy indicates signs of gastroesophagealvarices that is catenulate/nodular shape with or without red wales or spots and morethan 1.0cm of diameter.)

  • Decompensated liver cirrhosis Liver cancer

  • Liver histology conform to other chronic liver disease cause (exclude fatty liver)

  • Non-HBV avihepadnavirus infected acute and chronic hepatitis, autoimmune hepatitis,primary biliary cirrhosis, primary sclerosing cholangitis, inherited metabolic liverdisease, drug or toxic hepatitis, Alcoholic liver disease.

  • Have psychiatric history or uncontrollable epilepsy patient.

  • Uncontrollable diabetic patient

  • History of Hemoglobin disease (such as Alpha globin generation barrier anemia, Sicklecell deficiency, Spherocytosis) or Hemolytic anemia patients caused by other reasonslike autoimmunity.

  • 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: 192
Study Start date:
April 05, 2018
Estimated Completion Date:
June 30, 2021

Study Description

The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for reverse rate of gastroesophageal varices in patients with low-grade cirrhotic portal hypertension due to hepatitis B virus.

Connect with a study center

  • Ruijin Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Zhongshan Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai,
    China

    Active - Recruiting

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