A Phase 4 interventional study of Entecavir and Entecavir + Fuzheng Huayu in Portal Hypertension, sponsored by ShuGuang Hospital. Status unknown at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by ShuGuang Hospital · Phase 4, Interventional, and Treatment
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.
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 192 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →ShuGuang Hospital is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Tablet with Entrcavir
Drug: Entecavir
Tablet Tablet with Entrcavir+ Tablet with Fuzheng Huayu
Drug: Entecavir + Fuzheng Huayu
The subjects will be taking 1 Entecavir tablet per day for 96 weeks.
The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.
Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc
Time frame: 96 weeks
Grading varices
Time frame: 96 weeks
Incidence of Liver cancer
Time frame: 96 weeks
Noninvasive portal hypertension index
Time frame: 96 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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ShuGuang Hospital