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

Primary Purpose

Portal Hypertension

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir
Entecavir + Fuzheng Huayu
Sponsored by
ShuGuang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Hypertension focused on measuring Portal Hypertension, Fuzheng Huayu, Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Ruijin HospitalRecruiting
  • Shanghai Zhongshan HospitalRecruiting
  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Entecavir

Entecavir + Fuzheng Huayu

Arm Description

Tablet with Entrcavir

Tablet Tablet with Entrcavir+ Tablet with Fuzheng Huayu

Outcomes

Primary Outcome Measures

Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc
Grading varices
Incidence of Liver cancer
Noninvasive portal hypertension index

Secondary Outcome Measures

Full Information

First Posted
October 23, 2016
Last Updated
February 11, 2020
Sponsor
ShuGuang Hospital
Collaborators
Ruijin Hospital, Shanghai Zhongshan Hospital, Longhua Hospital, Shanghai Public Health Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02945956
Brief Title
Treatment of Low-grade Cirrhotic Portal Hypertension Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir
Official Title
A Randomized, Placebo-Controlled, Open-label, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir in Low-grade Cirrhotic Portal Hypertension Due to Hepatitis B Virus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital
Collaborators
Ruijin Hospital, Shanghai Zhongshan Hospital, Longhua Hospital, Shanghai Public Health Clinical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension
Keywords
Portal Hypertension, Fuzheng Huayu, Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Entecavir
Arm Type
Placebo Comparator
Arm Description
Tablet with Entrcavir
Arm Title
Entecavir + Fuzheng Huayu
Arm Type
Experimental
Arm Description
Tablet Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
The subjects will be taking 1 Entecavir tablet per day for 96 weeks.
Intervention Type
Drug
Intervention Name(s)
Entecavir + Fuzheng Huayu
Intervention Description
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.
Primary Outcome Measure Information:
Title
Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc
Time Frame
96 weeks
Title
Grading varices
Time Frame
96 weeks
Title
Incidence of Liver cancer
Time Frame
96 weeks
Title
Noninvasive portal hypertension index
Time Frame
96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JING LV, MD
Phone
+86-21-20256521
Email
liver125@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHENGHAI LIU, PHD,MD
Organizational Affiliation
ShuGuang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui Wang
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jiang
Facility Name
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Lv
Phone
021-20256409

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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