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

NCT02945956 | Unknown Phase 4 DMC

• 1 other identifier: SGHLC20161023003
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 3

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.

Conditions

Portal Hypertension

Keywords

Portal Hypertension; Fuzheng Huayu; Hepatitis 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

PLACEBO COMPARATOR

Tablet with Entrcavir

Drug: Entecavir

Entecavir + Fuzheng Huayu

EXPERIMENTAL

Tablet Tablet with Entrcavir+ Tablet with Fuzheng Huayu

Drug: Entecavir + Fuzheng Huayu

Interventions

Entecavir DRUG

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

Entecavir

Entecavir + Fuzheng Huayu DRUG

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

Entecavir + Fuzheng Huayu

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.）
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShuGuang Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Longhua Hospital: collaborator
• Shanghai Public Health Clinical Center: collaborator

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, Portal; Hepatitis B

Interventions

entecavir; fuzheng huayu

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• CHENGHAI LIU, PHD,MD

  ShuGuang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JING LV, MD

CONTACT

+86-21-20256521; liver125@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)