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Treatment of Moderate and Severe Cirrhotic Portal Hypertension Due to HBV With Fuzheng Huayu and Entecavir

Primary Purpose

Portal Hypertension

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Entecavir+Carvedilol

Entecavir+Carvedilol+ Fuzheng Huayu

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.）
Moderate and Severe 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
Low-grade Cirrhotic Portal Hypertension.
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 conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced 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 cell disease, 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 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/Carvedilol

Entecavir/Carvedilol/ Fuzheng Huayu

Arm Description

Tablet with Entrcavir and Carvedilol

Tablet with Entrcavir and Carvedilol+ 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

NCT ID

NCT02945982

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

1. Study Identification

Unique Protocol Identification Number

NCT02945982

Brief Title

Treatment of Moderate and Severe Cirrhotic Portal Hypertension Due to HBV 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 and Carvedilol in Moderate and Severe 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

Studies a U.S. FDA-regulated Device Product

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 Moderate and Severe 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

184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Entecavir/Carvedilol

Arm Type

Placebo Comparator

Arm Description

Tablet with Entrcavir and Carvedilol

Arm Title

Entecavir/Carvedilol/ Fuzheng Huayu

Arm Type

Experimental

Arm Description

Tablet with Entrcavir and Carvedilol+ Tablet with Fuzheng Huayu

Intervention Type

Drug

Intervention Name(s)

Entecavir+Carvedilol

Intervention Description

The subjects will be taking half a Carvedilol per day at first week and one Carvedilol per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day for 96 weeks.

Intervention Type

Drug

Intervention Name(s)

Entecavir+Carvedilol+ Fuzheng Huayu

Intervention Description

The subjects will be taking half a Carvedilol tablet per day at first week and one Carvedilol tablets per day from second week. At the same time,the subjects will be taking one 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

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.） Moderate and Severe 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 Low-grade Cirrhotic Portal Hypertension. 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 conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced 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 cell disease, 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 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

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Treatment of Moderate and Severe Cirrhotic Portal Hypertension Due to HBV With Fuzheng Huayu and Entecavir

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