Clinical Trial: Treatment of Moderate and Severe Cirrhotic Portal Hypertension Due to HBV With Traditional Chinese Medicine and Entecavir

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Assess the Efficacy and Safety of Traditional Chinese Medicine Combined With Entecavir and Carvedilol in Moderate and Severe Cirrh

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 Summary: 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.
Sponsor: ShuGuang Hospital

Current Primary Outcome:

  • Incidence rate of gastroesophageal varices [ Time Frame: 96 weeks ]
  • Reverse rate of gastroesophageal varices [ Time Frame: 96 weeks ]
  • Increase rate of gastroesophageal varices [ Time Frame: 96 weeks ]
  • Bleeding rate of gastroesophageal varices [ Time Frame: 96 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ShuGuang Hospital

Dates:
Date Received: October 23, 2016
Date Started: December 2016
Date Completion: June 2020
Last Updated: October 24, 2016
Last Verified: October 2016