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Status unknownNCT02945956Updated Feb 13, 2020

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

A Phase 4 interventional study of Entecavir and Entecavir + Fuzheng Huayu in Portal Hypertension, sponsored by ShuGuang Hospital. Status unknown at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by ShuGuang Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Portal Hypertension

Keywords

  • Portal Hypertension
  • Fuzheng Huayu
  • Hepatitis B
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's planned enrollment of 192 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

ShuGuang Hospital is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 varices that 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 controlled trial and sign the Informed Consent Form.

Exclusion criteria

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 gastroesophageal varices that is line shape with red wales or spots and less than 0.3cm of diameter,or snake large shape without red wales or spots and less than 1.0cm of diameter.)
  • Severe grade of portal hypertension(Endoscopy indicates signs of gastroesophageal varices that is catenulate/nodular shape with or without red wales or spots and more than 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 liver disease, 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, Sickle cell deficiency, Spherocytosis) or Hemolytic anemia patients caused by other reasons like 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 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study arms

  • Placebo comparator
    Entecavir

    Tablet with Entrcavir

    Drug: Entecavir

  • Experimental
    Entecavir + Fuzheng Huayu

    Tablet Tablet with Entrcavir+ Tablet with Fuzheng Huayu

    Drug: Entecavir + Fuzheng Huayu

Interventions

  • DrugEntecavir

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

  • DrugEntecavir + Fuzheng Huayu

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

06

What researchers measure

Primary outcomes

  1. Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc

    Time frame: 96 weeks

  2. Grading varices

    Time frame: 96 weeks

  3. Incidence of Liver cancer

    Time frame: 96 weeks

  4. Noninvasive portal hypertension index

    Time frame: 96 weeks

07

Study locations

3 of 3 sites recruiting
  • Ruijin Hospital
    Shanghai, China
    • hui Wang · Contact
    Recruiting
  • Shanghai Zhongshan Hospital
    Shanghai, China
    • Wei Jiang · Contact
    Recruiting
  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
    Shanghai, China
    • Jing Lv · Contact · 021-20256409
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02945956
Lead sponsor
ShuGuang Hospital
Collaborators
Ruijin Hospital, Shanghai Zhongshan Hospital, Longhua Hospital, Shanghai Public Health Clinical Center
Responsible party
Liu Chenghai (Professor, ShuGuang Hospital) — Principal investigator
First posted
Oct 26, 2016
Start date
Apr 5, 2018
Primary completion
Jun 2020 (estimated)
Completion
Jun 2021 (estimated)
Last update
Feb 13, 2020

Study contacts

JING LV, MD
Contact
liver125@126.com
+86-21-20256521
CHENGHAI LIU, PHD,MD
principal investigator · ShuGuang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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