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

NCT02945956 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2020-02-13

No results posted yet for this 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.

Conditions

  • Portal Hypertension

Interventions

DRUG

Entecavir

The subjects will be taking 1 Entecavir tablet per day for 96 weeks.

DRUG

Entecavir + Fuzheng Huayu

The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Longhua Hospital

    collaborator OTHER

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • ShuGuang Hospital

    lead OTHER

Principal Investigators

  • CHENGHAI LIU, PHD,MD · ShuGuang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2020-06-30
Completion
2021-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02945956 on ClinicalTrials.gov