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Trial record 109 of 347 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by ShuGuang Hospital
Sponsor:
Collaborators:
Ruijin Hospital
Shanghai Zhongshan Hospital
Longhua Hospital
Shanghai Public Health Clinical Center
Information provided by (Responsible Party):
Liu Chenghai, ShuGuang Hospital
ClinicalTrials.gov Identifier:
NCT02945956
First received: October 23, 2016
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Portal Hypertension
Drug: Entecavir + Placebo
Drug: Entecavir + Fuzheng Huayu
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, 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

Resource links provided by NLM:


Further study details as provided by ShuGuang Hospital:

Primary Outcome Measures:
  • Incidence rate of gastroesophageal varices [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Bleeding rate of gastroesophageal varices [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Increase rate of gastroesophageal varices [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Reverse rate of gastroesophageal varices [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Entecavir + Placebo
Tablet with Entrcavir+ Tablet with starch
Drug: Entecavir + Placebo
The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 96 weeks.
Experimental: Entecavir + Fuzheng Huayu
Tablet Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Drug: Entecavir + Fuzheng Huayu
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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.)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02945956

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

Sponsors and Collaborators
ShuGuang Hospital
Ruijin Hospital
Shanghai Zhongshan Hospital
Longhua Hospital
Shanghai Public Health Clinical Center
Investigators
Principal Investigator: CHENGHAI LIU, PHD,MD ShuGuang Hospital
  More Information

Responsible Party: Liu Chenghai, Professor, ShuGuang Hospital
ClinicalTrials.gov Identifier: NCT02945956     History of Changes
Other Study ID Numbers: SGHLC20161023003 
Study First Received: October 23, 2016
Last Updated: October 24, 2016
Health Authority: China: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by ShuGuang Hospital:
Portal Hypertension
Fuzheng Huayu
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Hypertension
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Entecavir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 08, 2016