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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02945982
Recruitment Status : Unknown
Verified February 2020 by Liu Chenghai, ShuGuang Hospital.
Recruitment status was:  Recruiting
First Posted : October 26, 2016
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Ruijin Hospital
Shanghai Zhongshan Hospital
Longhua Hospital
Shanghai Public Health Clinical Center
Information provided by (Responsible Party):
Liu Chenghai, ShuGuang Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Portal Hypertension Drug: Entecavir+Carvedilol Drug: Entecavir+Carvedilol+ Fuzheng Huayu Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Entecavir/Carvedilol
Tablet with Entrcavir and Carvedilol
 Drug: Entecavir+Carvedilol
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.
Experimental: Entecavir/Carvedilol/ Fuzheng Huayu
Tablet with Entrcavir and Carvedilol+ Tablet with Fuzheng Huayu
 Drug: Entecavir+Carvedilol+ Fuzheng Huayu
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.


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945982


Contacts
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Contact: JING LV, MD +86-21-20256521 liver125@126.com

Locations
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China
Ruijin Hospital Recruiting
Shanghai, China
Contact: hui Wang         
Shanghai Zhongshan Hospital Recruiting
Shanghai, China
Contact: Wei Jiang         
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, China
Contact: Jing Lv         
Sponsors and Collaborators
ShuGuang Hospital
Ruijin Hospital
Shanghai Zhongshan Hospital
Longhua Hospital
Shanghai Public Health Clinical Center
Investigators
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Principal Investigator: CHENGHAI LIU, PHD,MD ShuGuang Hospital
More Information
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Responsible Party: Liu Chenghai, Professor, ShuGuang Hospital
ClinicalTrials.gov Identifier: NCT02945982    
Other Study ID Numbers: SGHLC20161023004
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Chenghai, ShuGuang Hospital:
Portal Hypertension
Fuzheng Huayu
Hepatitis B
Additional relevant MeSH terms:
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Hypertension, Portal
Hypertension
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Entecavir
Carvedilol
Antiviral Agents
Anti-Infective Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists