NCT02945982

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2018

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 5, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

October 23, 2016

Last Update Submit

February 11, 2020

Conditions

Portal Hypertension

Keywords

Portal HypertensionFuzheng HuayuHepatitis B

Outcome Measures

Primary Outcomes (4)

  • Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc

    96 weeks

  • Grading varices

    96 weeks

  • Incidence of liver cancer

    96 weeks

  • Noninvasive portal hypertension index

    96 weeks

Study Arms (2)

Entecavir/Carvedilol

PLACEBO COMPARATOR

Tablet with Entrcavir and Carvedilol

Drug: Entecavir+Carvedilol

Entecavir/Carvedilol/ Fuzheng Huayu

EXPERIMENTAL

Tablet with Entrcavir and Carvedilol+ Tablet with Fuzheng Huayu

Drug: Entecavir+Carvedilol+ Fuzheng Huayu

Interventions

Entecavir+CarvedilolDRUG

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.

Entecavir/Carvedilol
Entecavir+Carvedilol+ Fuzheng HuayuDRUG

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.

Entecavir/Carvedilol/ Fuzheng Huayu

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ruijin Hospital

Shanghai, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hypertension, PortalHepatitis B

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Study Officials

  • CHENGHAI LIU, PHD,MD

    ShuGuang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JING LV, MD

CONTACT

+86-21-20256521liver125@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2016

First Posted

October 26, 2016

Study Start

April 5, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2021

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

CN(3)